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The Food and Drug Administration (FDA) warns the public against the purchase and use of the verified counterfeit versions of Rabipur PCEC rabies vaccine for human use.

Figure 1. Counterfeit version 1 of Rabipur® PCEC rabies vaccine for human use (Batch no. 3503)

Figure 2. Counterfeit version 2 of Rabipur® PCEC rabies vaccine for human use (Batch no. 3479)

The FDA, together with the Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., have verified that the above mentioned products in Figures 1 & 2 are counterfeit.

Counterfeit version 1 Counterfeit version 2 Authentic product
Shade of gray in box label Lighter shade Lighter shade Darker shade
Font format Not printed in Bold format Not printed in Bold format Printed in Bold format
QR Code Printed with darker ink Printed with darker ink Printed with lighter ink
Label of sterile syringe and needle Bears printed text

“E-Mail:CS@bd.com”

Bears printed text

“E-Mail:CS@bd.com”

“E-Mail:CS@bd.com” is not printed on label

 

Figure 3. Authentic product Rabipur® PCEC rabies vaccine for human use

The Batch numbers that were counterfeited as confirmed by the Marketing Authorization Holder (MAH), GlaxoSmithKline Philippines, Inc. are the following:

All healthcare professionals, local health centers, health institutions and the general public are hereby warned of these counterfeit versions 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 these verified counterfeit drug products 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 restrict the entry of these counterfeit versions of Rabipur PCEC rabies vaccine for human use.

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

For more information and inquiries, please e-mail us at info@fda.gov.ph. To report continuous sale or distribution of unregistered health products, kindly e-mail us via report@fda.gov.ph, 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 or e-mail cdrr@fda.gov.ph. 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 this advisory to all concerned is requested

FDA Advisory No. 2019-170