Category: Drugs Advisories

FDA Advisory No. 2020-1038 || Risks Associated with the Use of Favipiravir

The Food and Drug Administration (FDA) reminds all hospitals and healthcare providers to take extreme caution on the use of Favipiravir. The product has been observed to have teratogenic and embryotoxic effects in animal studies. Its use is contraindicated in known or suspected pregnancy.

The FDA advises the licensed physicians to confirm a negative pregnancy test before using Favipiravir in women with child-bearing potential. They should be advised to use or continue using effective contraceptive methods while in use and for another seven (7) days after taking the last dose. If pregnancy is suspected, discontinue its use.

Favipiravir is distributed in the sperm. Male patients should be informed of the risk associated on the use of the product. Instruct the patients to use the most effective contraceptive methods while using the product and for another seven (7) days after the last dose. Advise the use of condom and instruct not to have sexual intercourse with pregnant women.

Physicians are also advised to carefully monitor patients for other possible adverse effects such as increase in blood uric acid level, diarrhea, decrease in neutrophil count, and elevated liver enzymes — alanine aminotransferase (ALT) & aspartate aminotransferase (AST).

The benefit-risk balance should be carefully assessed prior to considering the use of the drug. Risks associated with the drug must be fully explained to patients.

All are enjoined to report adverse drug reactions (ADR) to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields. All hospitals with VigiFlow accounts are encouraged to report in the said platform. For inquiries email us at [email protected].

Attachment:-> FDA Advisory No.2020-1038

FDA Advisory No. 2020-1011-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

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

  1. “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

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

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 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]. 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:->

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1011-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

FDA Advisory No. 2020-1011 || Public Health Warning Against the Purchase and Use of the Following Unregistered Product “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

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

  1. “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration 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 its quality, safety and efficacy. Therefore, use 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.

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.2020-1011

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1011 || Public Health Warning Against the Purchase and Use of the Following Unregistered Product “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution”

FDA Advisory No. 2020-970-A || Babala sa Publiko Tungkol sa Paggamit ng Hindi Rehistradong Gamot na Copper Nanopeptide I.V. Drip

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

  1. Copper Nanopeptide I.V. Drip

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

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 gumamit 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]. 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.2020-970-A

FDA Advisory No. 2020-970 || Public Health Warning Against the Use of the Unregistered Drug Product Copper Nanopeptide I.V. Drip

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

  1. Copper Nanopeptide I.V. Drip

FDA Post-Marketing Surveillance (PMS) activities has verified that the abovementioned    drug product has not gone through the registration of the Agency and has not been issued  with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety, and efficacy. Therefore, use 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 product without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to use 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.2020-970

FDA Advisory No. 2020-854-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Alcohol 70% Solution 1L

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

  1. ALCOHOL 70% SOLUTION 1L

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

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 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 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://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.2020-854-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-854-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Alcohol 70% Solution 1L

FDA Advisory No. 2020-854 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Alcohol 70% Solution 1L

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

  1. Alcohol 70% Solution 1L

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration 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, use 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.

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 this 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]. 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.2020-854

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-854 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Alcohol 70% Solution 1L

FDA Advisory No. 2020-853-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Isopropyl Alcohol 70% Solution 4L

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

  • Isopropyl Alcohol 70% Solution 4L

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

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 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://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.2020-853-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-853-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Isopropyl Alcohol 70% Solution 4L

FDA Advisory No. 2020-853 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Isopropyl Alcohol 70% Solution 4L

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

  1. ISOPROPYL ALCOHOL 70% SOLUTION 4L

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration 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, use 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.

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 this 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]. 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.2020-853

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-853 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Isopropyl Alcohol 70% Solution 4L

FDA Advisory No. 2020-781-A || Amendment in the Pilot Implementation of eServices Portal for License to Operate (LTO) Application for Drugstores, RONPD, Drug Distributor, and Drug Traders

This is to inform the concerned stakeholders on the following amendment to FDA Advisory No. 2020-0781 entitled “Pilot Implementation of FDA eServices Portal for License to Operate (LTO) Application for Drugstores, RONPD, Drug Distributor, and Drug Traders”.

Read more:->FDA Advisory No.2020-0781-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-781-A || Amendment in the Pilot Implementation of eServices Portal for License to Operate (LTO) Application for Drugstores, RONPD, Drug Distributor, and Drug Traders

FDA Advisory No. 2020-811-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. Cefradine Capsules
  2. CSPC Amoxicillin Capsules
  3. OTC Chlorphenamine Maleate Tablets
  4. Rengongniuhuang Jiaxiaozuo Jiaonang

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

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]. 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.2020-811-A

FDA Advisory No. 2020-811 || 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. Cefradine Capsules
  2. CSPC Amoxicillin Capsules
  3. OTC Chlorphenamine Maleate Tablets
  4. Rengongniuhuang Jiaxiaozuo Jiaonang

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration 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.2020-811

FDA Advisory No. 2020-810 || Reminder on the Risk of QT Prolongation on the Use of Chloroquine or Hydroxychloroquine

The Food and Drug Administration (FDA) reminds all hospitals and healthcare providers to take extreme caution on the use of Chloroquine or Hydroxychloroquine due to the risk of QT prolongation. The FDA has recorded a total of 30 cases of QT prolongation on the use of the said products from 23 March 2020 to 12 May 2020.1

Chloroquine and hydroxychloroquine should be used with caution in patients with congenital or documented acquired QT prolongation and/or those with known risk factors for QT prolongation such as:

  • Cardiac disease e.g. heart failure, myocardial infarction;
  • Pro-arrhythmic conditions, e.g. bradycardia (<50 bpm);
  • History of ventricular dysrhythmias;
  • Uncorrected hypokalemia and/or hypomagnesemia; and
  • During concomitant administration with QT interval prolonging agents e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics, and some anti-infectives (including Azithromycin) as this may lead to an increased risk for ventricular arrhythmias, and sometimes a fatal outcome.2,3

The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, monitoring of adverse drug reactions should be strictly implemented.

All are enjoined to report adverse drug reactions to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields. For inquiries, email us at [email protected].

Attachment:-> FDA Advisory No.2020-810

FDA Advisory No. 2020-768-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Procain 2% Maxi 100 mL

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

  1. Procain 2% Maxi 100 mL

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). Dahil dito, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Samakatuwid, ang paggamit ng nasabing iligal na produkto ay maaaring magdulot ng panganib sa inyong kalusugan.

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]. 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.2020-768-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-768-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Procain 2% Maxi 100 mL

FDA Advisory No. 2020-768 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Procain 2% Maxi 100 mL

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

  1. Procain 2% Maxi 100 mL

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, use 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 product 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.2020-768

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-768 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Procain 2% Maxi 100 mL

FDA Advisory No. 2020-767-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na OTC Lianhua Qingwen Jiaonang

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

  1. OTC Lianhua Qingwen Jiaonang

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]. 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.2020-767-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-767-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na OTC Lianhua Qingwen Jiaonang

FDA Advisory No. 2020-767 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product OTC Lianhua Qingwen Jiaonang

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

  1. OTC Lianhua Qingwen Jiaonang

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. The consumption of such violative product may pose potential danger or injury if administered.

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.2020-767

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-767 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product OTC Lianhua Qingwen Jiaonang

FDA Advisory No. 2020-765 || Product Recall of All Batches of Ulipristal (as acetate) 5 mg Tablet (Esmya)

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected batches of the subject product from the market. The details of the product are as follows:

DRUG PRODUCT ULIPRISTAL (AS ACETATE) 5 mg TABLET (ESMYA)
REGISTRATION NO. DR-XY44905
BATCH NO./EXP. DATE ES145A SEPTEMBER 2021
ES146D APRIL 2022
ES147A AUGUST 2022
MANUFACTURER Cenexi – 17 Rue De Pontoise, 95520 Osny, France
UNDER LICENSE FROM Laboratoire HRA Pharma

– 15 Rue Beranger, 75003 Paris, France

IMPORTER/ DISTRIBUTOR

[Marketing Authorization Holder (MAH)]

Zuellig Pharma Corporation

– Km. 14 West Service Road, South Super Hi-Way corner Edison Ave., Brgy. Sun Valley, Parañaque City

The MAH pursued the voluntary recall of the drug product as a precautionary measure while its safety review by the European Medicines Agency (EMA) is still ongoing due to the potential risk of liver injury with symptoms such as tiredness, loss of appetite, abdominal pain, yellowing of the skin, darkening of the urine, nausea, and vomiting.

Ulipristal is a progesterone receptor modulator which is used for the pre-operative treatment or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal (as acetate) 5 mg Tablet (Esmya) is packed in an Alu-PVC/PVDC grey opaque duplex blister pack of 14 tablets
(box of 28’s and 84’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected batches of the drug product are instructed to discontinue further distribution, sale, and use. All patients currently taking the drug product are instructed to consult with their physician or healthcare provider about treatment options. Likewise, all consumers are advised not to purchase the affected product batches and may contact Zuellig Pharma Corporation at telephone number (632) 8405-5121 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches 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 the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-765

FDA Advisory No. 2020-749 || Product Recall of Specific Batches of Methotrexate 25 mg/mL (50 mg/2 mL) Solution for Injection (IM/IV) with Brand Names Alltrex and MPL Methoxil

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holders on the affected batches of the subject products from the market. The details of the products are as follows:

DRUG PRODUCT (1) METHOTREXATE 25 mg/mL (50 mg/2 mL) SOLUTION FOR INJECTION (IM/IV) (ALLTREX)
REGISTRATION NO. DRP-3138
BATCH NO./EXP. DATE NN8398B SEPTEMBER 2020
MANUFACTURER NAPROD LIFE SCIENCES PVT. LTD.
– G-17/1, MIDC, TARAPUR INDUSTRIAL AREA, BOISAR, DIST. THANE 401 506, INDIA
IMPORTER & DISTRIBUTOR [Marketing Authorization Holder (MAH)] MULTICARE PHARMACEUTICALS PHILIPPINES, INC.
– 26TH FLOOR RUFINO TOWER, 6784 AYALA AVENUE, MAKATI CITY

DRUG PRODUCT (2) METHOTREXATE 25 mg/mL (50 mg/2 mL) SOLUTION FOR INJECTION (IM/IV)
(MPL METHOXIL)
REGISTRATION NO. DRP-3138-01
BATCH NO./EXP. DATE NN8398C SEPTEMBER 2020
MANUFACTURER NAPROD LIFE SCIENCES PVT. LTD.
– G-17/1, MIDC, TARAPUR INDUSTRIAL AREA, BOISAR, DIST. THANE 401 506, INDIA
IMPORTER MULTICARE PHARMACEUTICALS PHILIPPINES, INC.
– 26TH FLOOR RUFINO TOWER, 6784 AYALA AVENUE, MAKATI CITY
DISTRIBUTOR (MAH) MULTI PRODUCTS LINE PHARMA, INC.
– UNIT 107 STERTEN PLACE CONDOMINIUM, 116 MAGINHAWA ST., TEACHER’S VILLAGE-EAST DILIMAN, QUEZON CITY

The MAHs pursued the voluntary recall of the drug products due to the microbial sterility issue found in certain batches provided to Columbia. The concerned batches were also exported to the Philippines. Therefore, the stated batches present quality and safety concerns.

Methotrexate is indicated in the treatment of gestational choriocarcinoma, acute lymphoblastic leukemia, and symptomatic control of psoriaris. The above-mentioned drug products are packed in a 3 mL flint glass vial (box of 1’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected batches of the drug products are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product batches and may contact Multicare Pharmaceuticals Philippines, Inc. at telephone number (02) 8811-0636 or mobile no. +639178854954 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches 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 the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-749

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-749 || Product Recall of Specific Batches of Methotrexate 25 mg/mL (50 mg/2 mL) Solution for Injection (IM/IV) with Brand Names Alltrex and MPL Methoxil

FDA Advisory No. 2020-748 || Product Recall of Specific Lot of Iron Sucrose 20 mg/mL Solution for Injection (IV) (Maxifer)

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected lot of the subject product from the market. The details of the product are as follows:

DRUG PRODUCT IRON SUCROSE 20 mg/mL SOLUTION
FOR INJECTION (IV) (MAXIFER)
REGISTRATION NO. DRP-2437-01
LOT NO./EXP. DATE B5A0185 JUNE 2020
MANUFACTURER CLARIS LIFESCIENCES LIMITED
– CHACHARWADI-VASANA, AHMEDABAD-382 213, INDIA
IMPORTER CLARIS LIFESCIENCES PHILIPPINES, INC. – 1108 11TH FLOOR, CITYLAND TOWER, 98 V.A. RUFINO ST. COR. VALERO ST., SALCEDO VILLAGE, MAKATI CITY
DISTRIBUTOR [Marketing Authorization Holder (MAH)] MULTICARE PHARMACEUTICALS PHILIPPINES, INC.
– 26TH FLOOR RUFINO TOWER, 6784 AYALA AVENUE, MAKATI CITY

 The MAH pursued the voluntary recall of the drug product due to the out-of-specification results on the assay, osmolarity, and pH stability. Therefore, the stated lot presents quality, safety, and efficacy concerns.

Iron Sucrose is an iron replacement indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD). Iron Sucrose 20 mg/mL Solution for Injection (IV) (Maxifer) is packed in a 5 mL clear glass ampoule in a blister pack (box of 5’s & 25’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lot and may contact Multicare Pharmaceuticals Philippines, Inc. at telephone number (02) 8811-0636 or mobile no. +639178854954 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lot 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 the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-748

FDA Advisory No. 2020-747 || Product Recall of Specific Lots of Chloramphenicol 5 mg/mL (w/v) Otic Solution (Klorobiz)

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected lots of the subject product from the market. The details of the product are as follows:

DRUG PRODUCT CHLORAMPHENICOL 5 mg/mL (w/v) OTIC SOLUTION (KLOROBIZ)
REGISTRATION NO. DRP-2867
LOT NO./EXP. DATE 8C04A AUGUST 2020
8C04B NOVEMBER 2020
MANUFACTURER ASHFORD PHARMACEUTICAL LABORATORIES, INC. – 145 P. OLIVEROS ST., ANTIPOLO CITY, RIZAL
TRADER

[Marketing Authorization Holder (MAH)]

PHARMABIZ SOLUTIONS, INC. – SUITE 203 COLUMBIAN BLDG., 160 WEST AVE., QUEZON CITY

The MAH pursued the voluntary recall of the drug product due to the out-of-specification result on its assay observed in the 24th-month of its shelf-life. The assay of a drug product determines the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. Therefore, the stated lots present quality, safety, and efficacy concerns.

Chloramphenicol in otic solution is indicated for the topical treatment of bacterial infection of the external ear caused by pathogens which are sensitive to it. It is active against a wide range of Gram-negative and Gram-positive organisms. Chloramphenicol 5 mg/mL Otic Solution (Klorobiz) is packed in a 10 mL LDPE plastic bottle.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lots of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lots and may contact Pharmabiz Solutions, Inc. at mobile no. +639274121330 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lots 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 the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-747

FDA Advisory No. 2020-746 || Product Recall of Specific Batches of Ranitidine (as Hydrochloride) 150 mg Film-Coated Tablet (Peptica)

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected batches of the subject product from the market. The details of the product are as follows:

DRUG PRODUCT RANITIDINE (AS HYDROCHLORIDE)

150 mg FILM-COATED TABLET (PEPTICA)

REGISTRATION NO. DR-XY32636
BATCH NO./EXP. DATE 1701784 May 2020
1900704 March 2022
1900705 March 2022
MANUFACTURER BERLIN PHARMACEUTICAL INDUSTRY CO. LTD. – 222 ROMKLAO ROAD, KLONGSAMPRAVET, LATKRABANG, BANGKOK 10520, THAILAND
IMPORTER/ DISTRIBUTOR

[Marketing Authorization Holder (MAH)]

LITTMAN DRUG CORPORATION – 3RD FLOOR NO. 3 JAIME CARDINAL SIN ST., PLEASANT HILLS, MANDALUYONG CITY

The MAH pursued the voluntary recall of the drug product due to the presence of the impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer) in the active pharmaceutical ingredient supplied or manufactured by SMS Lifesciences India Ltd., in India. Therefore, the stated batches present quality and safety concerns.

Ranitidine is indicated for the treatment of duodenal and gastric ulcer, including that associated with H pylori, NSAID-associated peptic ulcer, post-operative ulcer, acute reflux esophagitis, Zollinger-Ellison syndrome, chronic episodic dyspepsia, symptomatic relief in gastro-esophageal reflux disease, and prophylaxis of Mendelson’s syndrome. Ranitidine (as Hydrochloride) 150 mg Film-Coated Tablet (Peptica) is packed in a foil strip x 10 tablets (box of 100’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected batches of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product batches and may contact Littman Drug Corporation at telephone no. (02) 8696-3294 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches 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 the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-746

FDA Advisory No. 2020-745 || Product Recall of Specific Lot of Chloramphenicol 5 mg/mL Ophthalmic Solution (Klorobiz)

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder on the affected lot of the subject product from the market. The details of the product are as follows:

DRUG PRODUCT CHLORAMPHENICOL 5 mg/mL OPHTHALMIC SOLUTION (KLOROBIZ)
REGISTRATION NO. DRP-2605
LOT NO./EXP. DATE 7A04A SEPTEMBER 2020
MANUFACTURER ASHFORD PHARMACEUTICAL LABORATORIES, INC. – 145 P. OLIVEROS ST., ANTIPOLO CITY, RIZAL
TRADER

[Marketing Authorization Holder (MAH)]

PHARMABIZ SOLUTIONS, INC. – SUITE 203 COLUMBIAN BLDG., 160 WEST AVE., QUEZON CITY

The MAH pursued the voluntary recall of the drug product due to the out-of-specification result on its assay observed during the 24th-month out of its three (3) years shelf-life. The assay of a drug product determines the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. Therefore, the stated lot presents quality, safety, and efficacy concerns.

Chloramphenicol in ophthalmic solution is indicated for the treatment of acute bacterial conjunctivitis. Chloramphenicol 5 mg/mL Ophthalmic Solution (Klorobiz) is packed in a 10 mL plastic bottle.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lot and may contact Pharmabiz Solutions, Inc. at mobile no. +639274121330 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lot 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 the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-745

FDA Advisory No. 2020-566-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. DW (Alcosoft) Advanced Ethyl Alcohol 150mL
  2. Rubbing Alcohol 70% Isopropyl Alcohol 1 gallon
  3. Wynbert Soapmasters Inc. Isopropyl Alcohol 70% Solution
  4. Safety First Isopropyl Alcohol With Vitamin E & Guava Extract 70% Solution
  5. Richskin Germs Away with Vitamin E Ethyl Alcohol 70% Solution

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). Dahil dito, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Samakatuwid, ang paggamit ng mga 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]. 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.2020-566-A

FDA Advisory No. 2020-566 || 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. DW (Alcosoft) Advanced Ethyl Alcohol 150mL
  2. Rubbing Alcohol 70% Isopropyl Alcohol 1 gallon
  3. Wynbert Soapmasters Inc. Isopropyl Alcohol 70% Solution
  4. Safety First Isopropyl Alcohol With Vitamin E & Guava Extract 70% Solution
  5. Richskin Germs Away with Vitamin E Ethyl Alcohol 70% Solution

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, use 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.2020-566

FDA Advisory No. 2020-565-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. Shield All Purpose Disinfectant Kills 99.9%70 % Isopropyl Alcohol 1 Liter
  2. Isopropyl Alcohol 70% Solution 1 Liter
  3. Fastsion Ethyl Alcohol with Moisturizer 1 Liter
  4. Fastsion Hand Sanitizer with Moisturizer 1 Liter

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). Dahil dito, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Samakatuwid, ang paggamit ng mga 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]. 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.2020-565-A

FDA Advisory No. 2020-565 || 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. Shield All Purpose Disinfectant Kills 99.9%70 % Isopropyl Alcohol 1 Liter
  2. Isopropyl Alcohol 70% Solution 1 Liter
  3. Fastsion Ethyl Alcohol with Moisturizer 1 Liter
  4. Fastsion Hand Sanitizer with Moisturizer 1 Liter

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, use 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.2020-565

FDA Advisory No. 2020-564-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 gamot na:

  1. Champion 70% Isopropyl Alcohol
  2. Ethyl Alcohol Kills 99.9% Germs 70% Solution 1 Gallon
  3. Ethyl Alcohol 70% Solution 500ml
  4. Essentials Meca Alco-Scent 70% Isopropyl Alcohol
  5. Triple Care Formula ABV Antibacterial and Virus Ethyl Alcohol 80% Solution

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). Dahil dito, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa inyong kalusugan.

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]. 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.2020-564-A

FDA Advisory No. 2020-564 || 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. Champion 70% Isopropyl Alcohol
  2. Ethyl Alcohol Kills 99.9% Germs 70% Solution 1 Gallon
  3. Ethyl Alcohol 70% Solution 500ml
  4. Essentials Meca Alco-Scent 70% Isopropyl Alcohol
  5. Triple Care Formula ABV Antibacterial and Virus Ethyl Alcohol 80% Solution

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. The use of such violative products may pose potential danger or injury if administered.

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.2020-564

FDA Advisory No. 2020-514 || Product Recall of Specific Lots of Salbutamol (as sulfate) 2 mg/5 mL Syrup (Strawberry Flavor)

All healthcare professionals and the general public are hereby warned by the Food and Drug Administration (FDA) that affected lots of the subject product are being recalled from the market. The details of the product are as follows:

 

DRUG PRODUCT SALBUTAMOL (AS SULFATE) 2 mg/5 mL SYRUP (STRAWBERRY FLAVOR)
REGISTRATION NO. DR-XY30527
LOT NO./EXP. DATE NL001K APRIL 2020
NL003K OCTOBER 2020
MANUFACTURER [Marketing Authorization Holder (MAH)] INTERCHEMEX LABORATORIES, INC. — 900 PALACE ST., BF INTERNATIONAL, LAS PIÑAS CITY

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lots did not conform to the set specifications of assay test. The assay of a drug product determines the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. Therefore, the stated lots present quality and efficacy concerns.

Salbutamol is a selective ß2-agonist bronchodilator which provides short acting bronchodilation in reversible airways obstruction. It is indicated to rapidly treat asthma, bronchospasm, and reversible airways obstruction by widening the airways of the lungs in adults, adolescents, and children aged 2 to 12 years. Salbutamol (as sulfate) 2 mg/5 mL Syrup (Strawberry Flavor) is packed in a 60 mL amber glass bottle (box of l’s).

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lots of the drug product are instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lots and may contact Interchemex Laboratories, Inc. at telephone number (02) 8829-7605 for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lots 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 the abovementioned, kindly e-mail us at [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.2020-514

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