The Food and Drug Administration (FDA) advises the public against the purchase and use of the verified counterfeit version of drug product Co-Amoxiclav (Augmentin) Powder for Oral Suspension.
The FDA, together with the Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., have verified that the above mentioned product is counterfeit(please see attachment for further details).
The Batch No. 217883A having the expiry date Dec. 2020 was not imported by GSK.
All healthcare professionals, local health centers, health institutions and the general public are hereby warned of this counterfeit drug product in the market which pose potential danger or injury to consumers. Consumers, distributors and retailers are also reminded to purchase drug products only from FDA-licensed establishments.
Likewise, all establishments and outlets are hereby warned against selling and/or dispensing this verified counterfeit drug product with the foregoing features. The importation, selling or offering for sale, brokering, donating or possession without proof of legitimate purchase of such is in direct violation of Republic Act No. 9711, or the Food and Drug Administration Act of 2009, and Republic Act No. 8203, or the Special Law on Counterfeit Drugs, therefore a penalty shall be imposed.
The Bureau of Customs is urged to restrain the importation or entry of this counterfeit product.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is not sold, made available or used 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 or counterfeit health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.
Dissemination of the information to all concerned is requested
Attachment-> : FDA Advisory No. 2019-151