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FDA warns public, health centers over fake anti-rabies products

Published Jun 17, 2019 11:00 pm
By Betheena Unite Counterfeit anti-rabies vaccine products were recently discovered being sold in the market, prompting the Food and Drug Administration (FDA) to warn the public over it. In two consecutive advisory -- 2019-152 and 2019-153 -- the FDA said that counterfeit products of Anti-Rabies Serum (Equine) 5ml Vial and Purified Rabies Vaccine (Vero Cell) Speeda are being sold in the market. The public, medical professionals, and health institutions, through the advisories, were warned against purchasing and consuming the counterfeit medical products. According to the FDA, the discovered Anti-Rabies Serum (Equine) with brand name Equirab and with batch numbers A02717008 (version 1), A02717008 (version 2), and A02718012 (version 3) were confirmed as counterfeit by the Marketing Authorization Holder, BSV Bioscience Philippines, Inc. It was disclosed that the color in the box labels and in the vials of the counterfeit products are darker than the authentic ones. The labels of the counterfeit versions reflect New Marketlink Pharmaceuticals Corp. as the importer and distributor while the authentic product shows BSV Bioscience Phils., Inc as to the importer and New Marketlink Pharmaceuticals Corp. as the distributor. Further, the registration number of the authentic product is written as "D.R. NO.: BR-676 while the legitimate products have only "BR-676" on it. The Rx symbol in the vial of the authentic product is located close to the generic outline box while in the counterfeit product; it is positioned far below the generic outline box. Batches of confirmed fake Purified Rabies Vaccine (Vero Cell) Speeda, on the other hand, were identified as 201803067 (Version 1 & 3), 201708295 (Version 2), 201710356, and 201803069. Fake versions of this product can be spotted when the gray panel in the box label has a lighter shade; the text "Manufactured by" is not found in the box; the generic name is not enclosed in a generic outline box. If the barcodes are not printed properly as font and spacing are different; the upper edge of gray shading is near the text "rabies in human"; and the font color of printed text on the vial labels is lighter, then the product is not authentic, the FDA said. Consumers and distributors were also reminded to only purchase drug products from FDA-licensed establishments. All establishments and outlets were also warned by the FDA against selling the counterfeit products as it is in direct violation of R.A. 9711 or the Food and Drug Administration Act of 2009 and R.A. No. 8203 or the Special Law on Counterfeit Drugs. Meanwhile, the Bureau of Customs was then urged to restrain the importation of these counterfeit products. All local government units and law enforcement agencies were also asked to ensure that the counterfeit products are not sold in the market.
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