Category: Drugs Advisories

FDA Advisory No. 2020-548 || DIRECTIVES FOR RANITIDINE-CONTAINING PRODUCTS

Last year, an impurity, N-nitrosodimethylamine (NDMA), which was classified as a probable human carcinogen (a substance that could cause cancer) was found in some ranitidine products distributed globally. In the Philippines, the innovator, Ranitidine (Zantac), in 75 mg Tablet, 150 mg Tablet, 300 mg Tablet, and 25 mg/mL (50 mg/2 mL) Solution for Injection (IM/IV) presentations were voluntary recalled by GlaxoSmithKline Philippines, Inc. due to the detection of the said impurity in these drug products.

With the recent developments of this impurity such as increasing levels over time in some ranitidine products as discovered by the United States (US) Food and Drug Administration (FDA), the FDA Philippines acknowledges the importance of appropriate testing in order to ensure the provision of good quality, safe, and effective ranitidine products. The following drug products were tested accordingly and confirmed to have levels of NDMA below the acceptable limit:

PRODUCT INFORMATION REG. NO.
Ranitidine Hydrochloride 25 mg/mL Solution for Injection (IM/IV) (Siutec) DR-XY31808
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Nelstac) DRP-7171
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Ranistar) DRP-7171-01
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Aglotac) DRP-6135
Ranitidine (as hydrochloride) 25 mg/mL Sterile Solution for Injection (IM/IV) (Danitin) DRP-1107
Ranitidine (as hydrochloride) 25 mg/mL Sterile Solution for Injection (IM/IV) (Dynastin) DRP-1107-01
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Aciloc) DRP-869
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Eastidine) DRP-869-01
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Hacidac) DRP-869-02
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Apo-tin) DRP-6304
Ranitidine (as hydrochloride) 25 mg/mL Solution for Injection (IM/IV) (Primudine) DRP-6304-01
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Solution for Injection (Entac) DR-XY29322
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Solution for Injection (IM/IV) (Ulcin) DR-XY19686
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) (Qualran) DRP-159
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) (Effedine) DRP-159-03
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) (Zantricid) DRP-159-04
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) (Amkodine) DRP-159-05
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) (Geoxer) DRP-159-06
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) (Westran) DRP-159-07
Ranitidine (as hydrochloride) 25 mg/mL (50 mg/2 mL) Sterile Solution for Injection (IM/IV) (Ranipen) DRP-159-09
Ranitidine (as hydrochloride) 150 mg Tablet (Contracid) DRP-1237
Ranitidine (as hydrochloride) 150 mg Tablet (Ranae) DRP-1237-01
Ranitidine (as Hydrochloride) 150 mg Tablet (Radine) DR-XY32319
Ranitidine 150 mg Film-Coated Tablet (Zilatec) DRP-4651
Ranitidine (as hydrochloride) 300 mg Film-Coated Tablet (Alcera) DRP-4494
Ranitidine Hydrochloride + Tripotassium Bismuth Dicitrate + Sucralfate 84 mg/100 mg/300 mg Film-Coated Tablet (Albis) DR-XY44001

However, as precautionary measures for other registered but not tested ranitidine products for human use, the FDA Philippines directs the following:

  1. Immediate suspension of all operations (i.e., manufacture, importation, exportation, distribution, offer for sale) of concerned establishments, e.g., Marketing Authorization Holders (MAH), manufacturers, importers, exporters, distributor/sub-distributor, dealing with ranitidine products excluding those in the retail level. Ranitidine products currently available in the retail outlets can still be consumed;
  2. Strict utilization of either Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as recommended by the US FDA for every registered ranitidine product showing the analyses, in available batches of both the drug substance/active pharmaceutical ingredient (API) and the finished product, to determine the presence of NDMA;
  3. Submission of complete documents including the following:
    1. Certificates of Analysis of API and Finished Product
    2. Analytical Results
    3. Analytical raw data including chromatograms/spectra
    4. Other relevant data
  1. Provision of these documents must be done by all affected MAHs/establishments within ninety (90) calendar days from issuance of this advisory through submission to [email protected] containing the subject: Ranitidine-[Name of MAH/establishment]. A list of your registered ranitidine products with its registration numbers and the complete address of every API manufacturer/supplier must also be reflected in the body of your e-mail.

Resumption of operations of affected ranitidine products shall depend on the compliance of its MAH and non-submission of required documents shall lead to regulatory action/s without prior notice. Furthermore, the FDA Philippines shall still stringently monitor all ranitidine products under Post-Marketing Surveillance.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-548

FDA Advisory No. 2020-452 || Baseless Claims of “Prodex-B” as Anti-Viral Treatment for COVID-19

The Food and Drug Administration (FDA) reiterates to all health facilities and health professionals to follow the recommended treatment guidelines endorsed by the Department of Health (DOH) and the medical societies. This is in reference to the baseless claims on drug combination for the treatment and prevention of COVID-19.

The drug combination of Procaine and Dexamethasone with Vitamin B called “Prodex-B” is circulating in various media platforms and claims that it has promising effects against viral infections and diseases. However upon verification, the drug product “Prodex-B” is unregistered in this Office.

Procaine is an anesthetic used to reduce pain on injections, while Dexamethasone is a corticosteroid which must be used cautiously due to its side effects including immunosuppression or weaker immune system leading to vulnerability to infections. Furthermore, unregistered drug products have no guaranteed quality, safety and efficacy data which may lead to patient harm.

All consumers who have received the aforementioned drug are advised to monitor for any adverse reactions. For any observed adverse reaction, the individuals are advised to seek medical attention immediately and report to this Office at [email protected] and at E-Report at [email protected].

Attachment:-> FDA Advisory No.2020-452

FDA Advisory No. 2020-450 || Pharmacies to Dispense Hydroxychloroquine to Patients with Prescriptions for the Drug Use

The Food and Drug Administration (FDA) reiterates to all licensed drugstores and pharmacies to sell drugs and medicines with physician’s prescription. This is in reference to the alleged abrupt increase in the purchase of Hydroxychloroquine related to its possible use for COV1D-1 9.

Hydroxychloroquine is an antimalarial drug also indicated and importantly used for the treatment of patients with chronic inflammatory diseases such as rheumatoid arthritis, juvenile inflammatory arthritis, and systemic lupus erythematosus.

The FDA appeals to the pharmacies to cater to patients with established indications of this drug. Amidst the challenges of the COVID-19 pandemic, we do not want to leave our patients who have other life threatening and debilitating diseases with nothing to use for their treatment.

Attachment:-> FDA Advisory No.2020-450

FDA Advisory No. 2020-347-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Aural +
  2. Optivisum 30ml
  3. Aminofitin 50g
  4. Cardio trust 250 mg

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na mga produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng mga nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang mga gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected] Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/ Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:->FDA Advisory No.2020-347-A

FDA Advisory No. 2020-347 || Public Health Warning Against the Purchase and Use of the following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug products:

  1. Aural +
  2. Optivisum 30ml
  3. Aminofitin 50g
  4. Cardio trust 250 mg

Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected] You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-347

FDA Advisory No. 2020-346-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Lidocaine 2% E-100 With Epinephrine 1:100.000 Injectable Solution

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Lidocaine 2% E-100 With Epinephrine 1:100.000 Injectable Solution

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected] Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02)8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:->FDA Advisory No.2020-346-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-346-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Lidocaine 2% E-100 With Epinephrine 1:100.000 Injectable Solution

FDA Advisory No. 2020-346 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Lidocaine 2% E-100 With Epinephrine 1:100.000 Injectable Solution

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. LIDOCAINE 2% E -100 WITH EPINEPHRINE 1:100.000 Injectable Solution

FDA Post-Marketing Surveillance (PMS) activities has verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02)8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link:https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-346

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-346 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Lidocaine 2% E-100 With Epinephrine 1:100.000 Injectable Solution

FDA Advisory No. 2020-348-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Pekeng Bersyon ng Purified Rabies Vaccine (Vero Cell) Speeda 2.5 I.U. and 0.5 mL of Solvent Freeze-Dried Powder for Injection

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga pekeng bersyon ng Purified Rabies Vaccine (Vero Cell) Speeda 2.5 I.U. and 0.5 mL of Solvent Freeze-Dried Powder for Injection.

Ayon sa pagsusuri ng FDA kasama ang Marketing Authorization Holder (MAH), Pharma-Surrey International, Inc., ang mga nasabing produkto ay napatunayang peke. Ang paghahambing ng nakolektang pekeng mga gamot at kakaibang katangian ng tunay na produkto ay ang mga sumusunod:

Peke Tunay

1.   Ang shelf-life ay 24 na buwan lamang.

2.   “2.5 IU and 0.5 ml solvent” “VACCINE” “CAUTION” at “STORAGE” ay hindi makapal ang pagkasulat.

3.   Ang colon (:) na nakasulat sa Batch No., Mfg. Date, Exp. Date at Reg. No. ay hindi pantay.

4.   Iba sa tunay na produkto ang puwang sa pagitan ng “Imported and Distributed by, name of manufacturer, address of the manufacturer”.

1.  Ang shelf-life ay 36 na buwan.

2.    “2.5 IU and 0.5 ml solvent” “VACCINE” “CAUTION” at “STORAGE” ay makapal     ang pagkasulat.

3.    Ang colon (:) na nakasulat sa Batch No., Mfg. Date, Exp. Date at Reg. No. ay pantay.

4.   Pantay ang puwang sa pagitan ng “Imported and Distributed by, name of manufacturer, address of the manu-facturer”.

Ang lahat ng healthcare professionals at publiko ay binabalaan tungkol sa paglipana ng nasabing pekeng gamot sa merkado na maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito. Ang publiko ay pinapaalalahanan ring bumili lamang sa mga establisyamentong lisensyado ng FDA.

Gayundin, ang lahat ng establisyamento ay binabalaang huwag magbenta nitong produkto na nagtataglay ng mga nasabing katangian ng pekeng gamot. Ang pag-aangkat, pagbebenta at pamamahagi nito ay paglabag sa Republic Act No. 9711 o ang Food and Drug Administration Act of 2009 at Republic Act No. 8203 o ang Special Law on Counterfeit Drugs. Ang sino mang mapatunayang nagbebenta ng nasabing pekeng produkto ay mapaparusahan.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang pekeng produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga pekeng gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-348-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-348-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Pekeng Bersyon ng Purified Rabies Vaccine (Vero Cell) Speeda 2.5 I.U. and 0.5 mL of Solvent Freeze-Dried Powder for Injection

FDA Advisory No. 2020-348 || Public Health Warning Against the Purchase and Use of the Counterfeit Versions of Purified Rabies Vaccine (Vero Cell) Speeda 2.5 I.U. and 0.5 mL of Solvent Freeze-Dried Powder for Injection

The Food and Drug Administration (FDA) advises the public against the purchase and use of the counterfeit versions of Purified Rabies Vaccine (Vero Cell) Speeda 2.5 I.U. and 0.5 mL of Solvent Freeze-Dried Powder for Injection.

The FDA together with the Marketing Authorization Holder (MAH), Pharma-Surrey International, Inc., have verified that the above-mentioned sample drug products are counterfeit. The comparison of the collected counterfeit drug products and the distinguishing feature of the authentic are as follows:

Counterfeit Authentic
1.   The shelf-life is 24 months only.

2.   “2.5 IU and 0.5 ml solvent” “VACCINE” “CAUTION” and “STORAGE” are not bold.

3.   Colon (:) written on Batch No., Mfg. Date, Exp. Date and Reg. No. are not aligned.

4.   Spaces between “Imported and Distributed by, name of manufacturer, address of the manufacturer” are different from the authentic product.

1. The shelf-life is 36 months.

2.   “2.5 IU and 0.5 ml solvent” “VACCINE” “CAUTION” and “STORAGE” are bold.

3.    Colon (:) written on Batch No., Mfg. Date, Exp. Date and Reg. No. are aligned.

4.   Spaces between “Imported and Distributed by, name of manufacturer, address of the manufacturer” are equal.

All healthcare professionals and the general public are hereby warned as to the availability of this counterfeit drug product in the market which poses potential danger or injury to consumers. Consumers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing of this drug product with the abovementioned features of a counterfeit drug product. The importation, selling or offering for sale of such is in direct violation of Republic Act No. 9711 or the Food and Drug Administration Act of 2009, and Republic Act No. 8203 or the Special Law on Counterfeit Drugs. Anyone found selling the said counterfeit drug product will be penalized.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of counterfeit health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-348

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-348 || Public Health Warning Against the Purchase and Use of the Counterfeit Versions of Purified Rabies Vaccine (Vero Cell) Speeda 2.5 I.U. and 0.5 mL of Solvent Freeze-Dried Powder for Injection

FDA Advisory No. 2020-243-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. AT Angel Touch Haplas Liniment A Touch of Healing 60mL
  2. Kuto Free Amazing Oil JJL with Peppermint 60mL
  3. Methyl Salicylate Camphor + Menthol (Tyler Juanderherbs Liniment Oil) 30mL
  4. Methyl Salicylate Camphor + Menthol (Tyler Juanderherbs Liniment Oil with Sunflower Extract) 30mL
  5. Cellca Lujo Salve Balm Healing Power of 21 Botanicals “Lavandula” 10g
  6. Methyl Salicylate Camphor + Menthol (Tyler Vaporub) 10g

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-243-A

FDA Advisory No. 2020-243 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. AT Angel Touch Haplas Liniment A Touch of Healing 60mL
  2. Kuto Free Amazing Oil JJL with Peppermint 60mL
  3. Methyl Salicylate Camphor + Menthol (Tyler Juanderherbs Liniment Oil) 30mL
  4. Methyl Salicylate Camphor + Menthol (Tyler Juanderherbs Liniment Oil with Sunflower Extract) 30mL
  5. Cellca Lujo Salve Balm Healing Power of 21 Botanicals “Lavandula” 10g
  6. Methyl Salicylate Camphor + Menthol (Tyler Vaporub) 10g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-243

FDA Advisory No. 2020-242-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Albumin (Human) U.S.P. Kedbumin 25% Solution 12.5g 50mL

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Albumin (Human) U.S.P. Kedbumin 25% Solution 12.5g 50mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga pekeng gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-242-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-242-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Albumin (Human) U.S.P. Kedbumin 25% Solution 12.5g 50mL

FDA Advisory No. 2020-242 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Albumin (Human) U.S.P. Kedbumin 25% Solution 12.5g 50mL

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Albumin (Human) U.S.P. Kedbumin 25% Solution 12.5g 50mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-242

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-242 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Albumin (Human) U.S.P. Kedbumin 25% Solution 12.5g 50mL

FDA Advisory No. 2020-241-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Methyl Salicylate (Oil of Wintergreen) 25mL
  2. Ap-Ap Solution 3% solution 15mL
  3. EPHIC Gentian Violet 1% Solution 15mL
  4. EPHIC Eucalyptus Oil 15mL
  5. EPHIC Salicylic Acid 3% Solution
  6. Hydrogen Peroxide (Agua Oxigenada Solution) 60mL
  7. Povidone Iodine (Povidine 10% Solution) 15mL
  8. Ethyl Alcohol (70% Solution Electro Rubbing Alcohol Antiseptic Disinfectant With Moisturizer) 180mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-241-A

FDA Advisory No. 2020-241 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Methyl Salicylate (Oil of Wintergreen) 25mL
  2. Ap-Ap Solution 3% solution 15mL
  3. EPHIC Gentian Violet 1% Solution 15mL
  4. EPHIC Eucalyptus Oil 15mL
  5. EPHIC Salicylic Acid 3% Solution
  6. Hydrogen Peroxide (Agua Oxigenada Solution) 60mL
  7. Povidone Iodine (Povidine 10% Solution) 15mL
  8. Ethyl Alcohol (70% Solution Electro Rubbing Alcohol Antiseptic Disinfectant With Moisturizer) 180mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-241

FDA Advisory No. 2020-240-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Camphor + Menthol Med Rub Herbs & Oil Balm Medicated with 7 Herbs & V.C.O. (Virgin Coconut Oil) 150 gms (Red container)
  2. Camphor + Menthol Med Rub Herbs & Oil Balm Medicated with 7 Herbs & V.C.O. (Virgin Coconut Oil) 150 gms (Blue container)
  3. New! Pito-Pito Healing Spirits Herbal Wonder Oil 120mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-240-A

FDA Advisory No. 2020-240 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Camphor + Menthol Med Rub Herbs & Oil Balm Medicated with 7 Herbs & V.C.O. (Virgin Coconut Oil) 150 gms (Red container)
  2. Camphor + Menthol Med Rub Herbs & Oil Balm Medicated with 7 Herbs & V.C.O. (Virgin Coconut Oil) 150 gms (Blue container)
  3. New! Pito-Pito Healing Spirits Herbal Wonder Oil 120mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-240

FDA Advisory No. 2020-192-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong mga gamot na:

  1. Dragon Oil 12mL
  2. El Shaddai Sunshine Ugat Menthol Oil
  3. El Shaddai Sunshine Ugat Pepper Mint Oil
  4. Ugat Ginger Pain Reliever

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na mga produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng mga nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang mga gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:-> FDA Advisory No.2020-192-A

FDA Advisory No. 2020-192 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Dragon Oil 12mL
  2. El Shaddai Sunshine Ugat Menthol Oil
  3. El Shaddai Sunshine Ugat Pepper Mint Oil
  4. Ugat Ginger Pain Reliever

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link:https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-192

FDA Advisory No. 2020-191-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Hallelujah Rub Eucalyptus 25 g
  2. Yulin Zheng Gu Shui 30 ml
  3. Snow King Medicated Oil 15 ml
  4. Health Source Vitamin C Softgel 100’s

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na mga produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng mga nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration tingnan kung ang mga gamot ay rehistrado sa FDA bago bilhin, sa Maaari ring tingnan ang FDA Registration number sa label ng produkto. hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:-> FDA Advisory No.2020-191-A

FDA Advisory No. 2020-191 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Hallelujah Rub Eucalyptus 25 g
  2. Yulin Zheng Gu Shui 30 ml
  3. Snow King Medicated Oil 15 ml
  4. Health Source Vitamin C Softgel 100’s

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link:https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-191

FDA Advisory No. 2020-190-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong mga gamot na:

  1. Methyl Salicylate + Camphor + Menthol (Sced Panyawan Plus Liniment) 60 mL
  2. Methyl Salicylate + Camphor + Menthol (Sced Panyawan Plus Liniment) 30 mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na mga produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng mga nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang mga gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:-> FDA Advisory No.2020-190-A

FDA Advisory No. 2020-190 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug products:

  1. Methyl Salicylate + Camphor + Menthol (Sced Panyawan Plus Liniment) 60 mL
  2. Methyl Salicylate + Camphor + Menthol(Sced Panyawan Plus Liniment) 30 mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link:https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-190

FDA Advisory No. 2020-189-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong mga gamot na:

  1. Pure Acetone 60 ML
  2. Aceite De Alcamporado 25mL
  3. Salicylic Acid 10g/100m 50 mL
  4. Methyl Salicylate 10% 100 ml (Kris Mega Haplas Oil Pluz-3) 60mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na mga produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng mga nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang mga gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:->FDA Advisory No.2020-189-A

FDA Advisory No. 2020-189 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Pure Acetone 60 ML
  2. Aceite De Alcamporado 25mL
  3. Salicylic Acid 10g/100m 50 mL
  4. Methyl Salicylate 10% 100 ml (Kris Mega Haplas Oil Pluz-3) 60mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-189

FDA Advisory No. 2020-188-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. New Clest Essential Milk Skin Lightening 105ml
  2. Clest Pain Killer Extra Strength Herbal Liniment 150ml

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga pekeng gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-188-A

FDA Advisory No. 2020-188 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. New Clest Essential Milk Skin Lightening 105ml
  2. Clest Pain Killer Extra Strength Herbal Liniment 150ml

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-188

FDA Advisory No. 2020-187-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Pekeng Bersyon ng Verorab Rabies Vaccine For Human Use, Prepared On Cell Cultures (Inactivated)

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga pekeng bersyon ng Verorab Rabies Vaccine For Human Use, Prepared On Cell Cultures (Inactivated):(please see attachment below for the counterfeit versions vs. authentic versions)

Ayon sa pagsusuri ng FDA kasama ang Marketing Authorization Holder (MAH), Sanofi Pasteur Inc., ang nasabing produkto ay napatunayang peke. Ang paghahambing ng nakolektang pekeng mga gamot at kakaibang katangian ng tunay na produkto ay ang mga sumusunod:

Counterfeit Authentic
  • Ang karton ay may mababang kalidad na walang barnis o suson sa papel.
  • Ang kulay ng marka (label) sa vial ay matingkad na pula.
  • Ang pagkaposisyon ng marka (label) sa pre-filled syringe ay pabaligtad at may kulay na matingkad na pula.
  • Ang karton ay barnisado at mukhang makintab.
  • Ang kulay ng marka (label) sa vial ay makulimlim na pula.
  • Ang pagkaposisyon ng marka (label) sa pre-filled syringe ay nakatayo at may kulay na makulimlim na pula.

Ang lahat ng healthcare professionals at publiko ay binabalaan tungkol sa paglipana ng nasabing pekeng gamot sa merkado na maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito. Ang publiko ay pinapaalalahanan ring bumili lamang sa mga establisyamentong lisensyado ng FDA.

Gayundin, ang lahat ng establisyamento ay binabalaang huwag magbenta nitong produkto na nagtataglay ng mga nasabing katangian ng pekeng gamot. Ang pagaangkat, pagbebenta at pamamahagi nito ay paglabag sa Republic Act No. 9711 o ang Food and Drug Administration Act of 2009 at Republic Act No. 8203 o ang Special Law on Counterfeit Drugs. Ang sino mang mapatunayang nagbebenta ng nasabing pekeng produkto ay mapaparusahan.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang pekeng produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga pekeng gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:->FDA Advisory No.2020-187-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-187-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Pekeng Bersyon ng Verorab Rabies Vaccine For Human Use, Prepared On Cell Cultures (Inactivated)

FDA Advisory No. 2020-187 || Public Health Warning Against the Purchase and Use of the Counterfeit Versions of Verorab Rabies Vaccine For Human Use, Prepared On Cell Cultures (Inactivated)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the counterfeit versions of Verorab Rabies Vaccine For Human Use, Prepared On Cell Cultures (Inactivated): (please see attachment below for the counterfeit versions vs. authentic versions)

The FDA together with the Marketing Authorization Holder (MAH), Sanofi Pasteur Inc., have verified that the above-mentioned sample drug product is counterfeit. The comparison of the collected counterfeit drug products and the distinguishing feature of the authentic are as follows:

Counterfeit Authentic
  • Box is of poor quality with no varnish or coating on the paper
  • Vial color label is bright red
  • Pre-filled syringe label orientation is inverted and its color is bright red.
  • Box is varnished and appears glossy
  • Vial color label is dull red
  • Pre-filled syringe label orientation is upright and its color is dull red.

All healthcare professionals and the general public are hereby warned as to the availability of this counterfeit drug product in the market which poses potential danger or injury to consumers. Consumers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing of this drug product with the abovementioned features of a counterfeit drug product. The importation, selling or offering for sale of such is in direct violation of Republic Act No. 9711 or the Food and Drug Administration Act of 2009, and Republic Act No. 8203 or the Special Law on Counterfeit Drugs. Anyone found selling the said counterfeit drug product will be penalized.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-187

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-187 || Public Health Warning Against the Purchase and Use of the Counterfeit Versions of Verorab Rabies Vaccine For Human Use, Prepared On Cell Cultures (Inactivated)

FDA Advisory No. 2020-186-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Irish Pain Killer Extra Strength
  2. MD® Skin Fighter 8g
  3. Ong Hit Thong Mui

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga pekeng gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-186-A

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