Category: Drugs Advisories

FDA Advisory No. 2020-1217 || Product Recall of Specific Lot of Ethyl Alcohol 70% Solution (Michael)

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

DRUG PRODUCT ETHYL ALCOHOL 70% SOLUTION (MICHAEL)

Net Content: 470 mL

REGISTRATION NO. DRHR-1084
LOT NO./ EXP. DATE MEA-20002 29 APRIL 2022
MANUFACTURER G.V. Cosmetics, Inc.

– Wallent Compound, Tanada Subdivision, Marulas, Valenzuela City

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lot contains Methanol.

Methanol is a toxic alcohol that is used industrially as a solvent, pesticide, and alternative fuel source which can be absorbed into the body by inhalation, ingestion, skin contact, or eye contact. Effects of short-term exposure (less than 8-hours) may cause an accumulation of acid in the blood (metabolic acidosis), blindness, and death. Initial adverse health effects due to methanol poisoning include drowsiness, reduced level of consciousness (CNS depression), confusion, headache, dizziness, inability to coordinate muscle movement (ataxia), and heart and respiratory (cardiopulmonary) failure. Chronic poisoning from repeated exposure may produce inflammation of the eye (conjunctivitis), insomnia, stomach disturbances, visual failure, and irritation of the skin (dermatitis)

Ethyl Alcohol (at 70% concentration) is used as a topical antiseptic and disinfectant. Ethyl Alcohol 70% Solution (Michael) is packed in a green HDPE bottle.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the product are instructed to discontinue further distribution, sale, and use. Likewise, all consumers are advised not to use or purchase the affected product lot and may contact G.V. Cosmetics, Inc. at [email protected] or tel. no. +632 2931913 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 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 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.2020-1217

FDA Advisory No. 2020-1216 || Product Recall of Specific Lot of Isopropyl Alcohol 70% Rubbing Solution with Moisturizer

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

DRUG PRODUCT ISOPROPYL ALCOHOL 70% RUBBING SOLUTION WITH MOISTURIZER

Net Content: 1 Gallon

REGISTRATION NO. DRHR-1857
LOT NO./EXP. DATE 052076 MAY 2022
MANUFACTURER Greatstar Laboratories

– Sitio Calit, Banaoang, Calasiao, Pangasinan

DISTRIBUTOR Genace Pharma Distributor

– #19 Diamond St., Greenheights Village, Brgy. San Isidro, Parañaque City

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lot contains only 21.6% of Isopropyl Alcohol which is less than 70%, as labeled, and determined the presence of Methanol.

Methanol is a toxic alcohol that is used industrially as a solvent, pesticide, and alternative fuel source which can be absorbed into the body by inhalation, ingestion, skin contact, or eye contact. Effects of short-term exposure (less than 8-hours) may cause an accumulation of acid in the blood (metabolic acidosis), blindness, and death. Initial adverse health effects due to methanol poisoning include drowsiness, reduced level of consciousness (CNS depression), confusion, headache, dizziness, inability to coordinate muscle movement (ataxia), and heart and respiratory (cardiopulmonary) failure. Chronic poisoning from repeated exposure may produce inflammation of the eye (conjunctivitis), insomnia, stomach disturbances, visual failure, and irritation of the skin (dermatitis).

Isopropyl Alcohol (at 70% concentration) is used as a topical antiseptic and disinfectant. Isopropyl Alcohol 70% Rubbing Solution with Moisturizer is packed in an opaque white HDPE plastic bottle.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the product are instructed to discontinue further distribution, sale, and use. Likewise, all consumers are advised not to use or purchase the affected product lot and may contact Greatstar Laboratories at mobile no. +639178558150 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 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 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.2020-1216

FDA Advisory No. 2020-1131-A || Paalala sa Publiko Tungkol sa Paggamit ng Dexamethasone

Ang Food and Drug Administration (FDA) ay mahigpit na pinapaalalahanan ang publiko na ang gamot na Dexamethasone ay isang prescription drug. Kailangan ang reseta at pagsubaybay ng isang lisensiyadong doktor sa paggamit ng gamot na ito. Mayroong mga produktong Dexamethasone na kasalukuyang nakarehistro sa FDA. Ang gamot na ito ay dapat na ipagbili lamang ng mga lisensyadong establisyemento sa mga pasyente na may reseta ng doktor. Ang pagbebenta ng hindi rehistradong Dexamethasone o pagbebenta nito sa online platforms ay mahigpit na ipinagbabawal.

Ang Dexamethasone ay isang steroid at inirereseta ng isang lisensyadong doktor base sa kondisyong medikal ng pasyente. Ang maling paggamit ng gamot na ito ay maaaring magdulot ng mga hindi mabuting epekto sa katawan tulad ng:

  • Paghina ng resistensiya ng katawan laban sa impeksiyon
  • Pagdudugo sa loob ng tiyan o ulser
  • Pagiging marupok ng buto
  • Panghihina ng mga kalamnan
  • Mabagal na paggaling ng sugat
  • Ang matagal na paggamit ng gamot ay maaaring makaapekto sa paglaki ng mga sanggol at bata
  • Pamamanas
  • Diyabetis o alta presyon

Ang biglaang pagtigil sa pag-inom ng gamot ay maaaring magdulot ng mga withdrawal symptoms tulad ng pagbaba ng blood pressure, shock, at coma.1

Ang lahat ay hinihikayat na ireport ang pagbebenta o paggamit ng gamot na ito na walang wastong reseta sa FDA Center for Drug Regulation and Research e-mail: [email protected]. Ang sinomang makaranas ng hindi mabuting epekto ng gamot o adverse reactions ay kailangang magpakonsulta agad sa doktor at ireport sa https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH. Ang lahat ng mga lalabag sa mga ito ay may kaukulang parusang naaayon sa batas.

Para sa patnubay ng lahat.

Attachment:-> FDA Advisory No.2020-1131-A

FDA Advisory No. 2020-1131 || Reminder on the Use of Dexamethasone

The Food and Drug Administration (FDA) strongly reminds the public that Dexamethasone is a prescription drug and should strictly be used under the supervision of a licensed physician. There are Dexamethasone products that are currently registered with the FDA. The drug should be only dispensed by licensed establishments to patients with valid prescription. The sale of unregistered Dexamethasone or sale of the drug without valid prescription or through online platforms is strictly prohibited.

Dexamethasone is a steroid drug and is prescribed by a licensed physician based on the patient’s medical condition. Misuse or unsupervised chronic use of this drug may lead to serious adverse reactions such as:

  • Immunosuppression or impairment of the body’s ability to fight infections
  • Gastrointestinal bleeding and ulcers
  • Electrolyte imbalance
  • Osteoporosis
  • Muscle weakness
  • Poor wound healing
  • Prolonged use of the drug may cause suppression of growth among infants and children
  • Obesity

If stopped abruptly, it may cause withdrawal symptoms such as hypotension, shock, and coma.1

All are enjoined to report the dispense and/or use of the drug without a valid prescription to FDA Center for Drug Regulation and Research at [email protected] . For any observed adverse reactions with the use of the drug, seek medical attention immediately and report to the FDA at https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH  and fill out all the required fields. All violators shall be dealt with legal actions.

For your guidance.

Attachment:->FDA Advisory No.2020-1131

FDA Advisory No. 2020-1085 || Product Recall of Specific Lot of Isopropyl Alcohol 70% (v/v) Solution (Zach)

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

DRUG PRODUCT ISOPROPYL ALCOHOL 70% (v/v) SOLUTION (ZACH)

Net Content: 500 mL

REGISTRATION NO. HRP-268
LOT NO./EXP. DATE G2003005 MARCH 2022
MANUFACTURER Azarias Pharmaceutical Laboratories, Inc. – 001 Service Road, Zone 1, Pandayan, Meycauayan, Bulacan

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lot contains only 44.6% of Isopropyl Alcohol which is less than 70%, as labeled, and determined the presence of Methanol.

Methanol is a toxic alcohol that is used industrially as a solvent, pesticide, and alternative fuel source which can be absorbed into the body by inhalation, ingestion, skin contact, or eye contact. Effects of short-term exposure (less than 8-hours) may cause an accumulation of acid in the blood (metabolic acidosis), blindness, and death. Initial adverse health effects due to methanol poisoning include drowsiness, reduced level of consciousness (CNS depression), confusion, headache, dizziness, inability to coordinate muscle movement (ataxia), and heart and respiratory (cardiopulmonary) failure. Chronic poisoning from repeated exposure may produce inflammation of the eye (conjunctivitis), insomnia, stomach disturbances, visual failure, and irritation of the skin (dermatitis)[1].

Isopropyl Alcohol (at 70% concentration) is used as a topical antiseptic and disinfectant. Isopropyl Alcohol 70% (v/v) Solution (Zach) is packed in an opaque white HDPE plastic bottle with blue flip top cap.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the product are instructed to discontinue further distribution, sale, and use. Likewise, all consumers are advised not to use or purchase the affected product lot and may contact Azarias Pharmaceutical Laboratories, Inc. at telephone number +632 8475-9119 or mobile no. +639616342868 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 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 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.2020-1085

FDA Advisory No. 2020-1084 || Public Health Warning Against the Purchase and Use of Adulterated, Misbranded, and Unregistered Health Product “Ethyl Alcohol 70% 1 L”

The Food and Drug Administration (FDA) warns the public against the purchase and use of adulterated, misbranded, and unregistered health product which poses potential danger or injury to health:

  1. “Ethyl Alcohol 70% 1 L”

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned health product has not gone through the registration process of the Agency and not been issued with proper market authorization, e.g., Certificate of Product Registration.

The FDA laboratory analysis showed that the product does not contain 70% Ethyl Alcohol, as labeled, but instead consists of Methanol.

Methanol is a toxic alcohol that is used industrially as a solvent, pesticide, and alternative fuel source which can be absorbed into the body by inhalation, ingestion, skin contact, or eye contact. Effects of short-term exposure (less than 8-hours) may cause an accumulation of acid in the blood (metabolic acidosis), blindness, and death. Initial adverse health effects due to methanol poisoning include drowsiness, reduced level of consciousness (CNS depression), confusion, headache, dizziness, inability to coordinate muscle movement (ataxia), and heart and respiratory (cardiopulmonary) failure. Chronic poisoning from repeated exposure may produce inflammation of the eye (conjunctivitis), insomnia, stomach disturbances, visual failure, and irritation of the skin (dermatitis)[1].

In light of the foregoing, the public is advised to always check if a health product has been registered with the FDA before purchasing it by making use of the embedded Search feature at the FDA website (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 manufacture, distribute, sell, or offer for sale the adulterated/misbranded/unregistered health product. Pursuant to Section 11, subsections (a) and (b) of Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the following acts and the causing thereof: (a) the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded; and (b) the adulteration or misbranding of any health product are prohibited.

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

For more information or inquiries, please e-mail us at [email protected]. To report any sale or distribution of the abovementioned, kindly e-mail us via [email protected] You may also call the Center for Drug Regulation and Research (CDRR) 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 this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1084

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1084 || Public Health Warning Against the Purchase and Use of Adulterated, Misbranded, and Unregistered Health Product “Ethyl Alcohol 70% 1 L”

FDA Advisory No. 2020-1083 || Public Health Warning Against the Purchase and Use of Adulterated, Misbranded, and Unregistered Health Product “Ethyl Alcohol 70% 1 L”

The Food and Drug Administration (FDA) warns the public against the purchase and use of the adulterated, misbranded, and unregistered health product which poses potential danger or injury to health:

  1. “Ethyl Alcohol 70% 1 L”

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned health product has not gone through the registration process of the Agency and not been issued with proper market authorization, e.g., Certificate of Product Registration.

The FDA laboratory analysis showed that the product does not contain 70% Ethyl Alcohol, as labeled, but instead consists of Methanol.

Methanol is a toxic alcohol that is used industrially as a solvent, pesticide, and alternative fuel source which can be absorbed into the body by inhalation, ingestion, skin contact, or eye contact. Effects of short-term exposure (less than 8-hours) may cause an accumulation of acid in the blood (metabolic acidosis), blindness, and death. Initial adverse health effects due to methanol poisoning include drowsiness, reduced level of consciousness (CNS depression), confusion, headache, dizziness, inability to coordinate muscle movement (ataxia), and heart and respiratory (cardiopulmonary) failure. Chronic poisoning from repeated exposure may produce inflammation of the eye (conjunctivitis), insomnia, stomach disturbances, visual failure, and irritation of the skin (dermatitis)[1].

In light of the foregoing, the public is advised to always check if a health product has been registered with the FDA before purchasing it by making use of the embedded Search feature at the FDA website (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 manufacture, distribute, sell, or offer for sale the adulterated/misbranded/unregistered health product. Pursuant to Section 11, subsections (a) and (b) of Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the following acts and the causing thereof: (a) the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded; and (b) the adulteration or misbranding of any health product are prohibited.

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

For more information or inquiries, please e-mail us at [email protected]. To report any sale or distribution of the abovementioned, kindly e-mail us via [email protected] You may also call the Center for Drug Regulation and Research (CDRR) 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 this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1083

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1083 || Public Health Warning Against the Purchase and Use of Adulterated, Misbranded, and Unregistered Health Product “Ethyl Alcohol 70% 1 L”

FDA Advisory No. 2020-1056 || Product Recall of Specific Lot of Isopropyl Alcohol 70% Rubbing Solution with Moisturizer

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

DRUG PRODUCT ISOPROPYL ALCOHOL 70% RUBBING SOLUTION WITH MOISTURIZER

Net Content: 150 mL

REGISTRATION NO. DRHR-1857
LOT NO./EXP. DATE 081917                                      AUGUST 2021
MANUFACTURER Greatstar Laboratories

— Sitio Calit, Banaoang, Calasiao, Pangasinan

DISTRIBUTOR Genace Pharma Distributor

— #19 Diamond St., Greenheights Village, Brgy. San Isidro, Parañaque City

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lot contains only 48.53% of Isopropyl Alcohol which is less than 70%, as labeled, and determined the presence of Methanol.

Methanol is a toxic alcohol that is used industrially as a solvent, pesticide, and alternative fuel source which can be absorbed into the body by inhalation, ingestion, skin contact, or eye contact. Effects of short-term exposure (less than 8-hours) may cause an accumulation of acid in the blood (metabolic acidosis), blindness, and death. Initial adverse health effects due to methanol poisoning include drowsiness, reduced level of consciousness (CNS depression), confusion, headache, dizziness, inability to coordinate muscle movement (ataxia), and heart and respiratory (cardiopulmonary) failure. Chronic poisoning from repeated exposure may produce inflammation of the eye (conjunctivitis), insomnia, stomach disturbances, visual failure, and irritation of the skin (dermatitis)1.

Isopropyl Alcohol (at 70% concentration) is used as a topical antiseptic and disinfectant. Isopropyl Alcohol 70% Rubbing Solution with Moisturizer is packed in a translucent white HDPE plastic bottle.

Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the product are instructed to discontinue further distribution, sale, and use. Likewise, all consumers are advised not to use or purchase the affected product lot and may contact Greatstar Laboratories at mobile no. +639178558150 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 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 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.2020-1056

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 info[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 e[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

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