Thursday, 12 April 2018 13:58

PUBLIC ALERT NO: 07/2018Falsified Augmentin Products Circulating In Cameroun

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The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified of the circulation of a falsified version of Augmentin (Amoxycillin + Clavulanate potassium) in Cameroun.

Amoxycillin + Clavulanic acid is used to treat a range of bacterial infections and is listed as a WHO Essential Medicine.

The existence of the falsified product was reported to WHO in early 2018 by an NGO. The NGO reported that this product was available at patient level in a street market of Douala, Litorral Region, Cameroun. Samples were sent for quality-assurance laboratory testing and the result shared with WHO. The result of analysis did not identify any of the expected active ingredient.

The packaging of the falsified product appears to be a close imitation of the genuine product manufactured by GSK (GlaxoSmithKline), although there are some mistakes on the packaging inscription. The source(s) of the falsified product has not yet been identified.

The stated manufacturer (GSK) has confirmed they did not manufacture this falsified version. No known adverse reactions to this product have been reported.

The details of the falsified product are;

Product Name Augmentin (Amoxycillin+ Clavulanate potassium)
Batch Number 562626
Expiry Date MAY 2019
Manufacturing Date MAY 2016
Declared active ingredient

500mg Amoxycillin Trihydrate E.P

125mg Clavulanate Potassium B.P

Stated Manufacturer GSK GlaxoSmithKline

NAFDAC advices wholesalers, distributors and pharmacies that products should be obtained from authentic and reliable sources. Increased vigilance is hereby encouraged within the supply chain to avoid infiltration of the falsified product.

NAFDAC implores healthcare providers to ensure vigilance to prevent the administration of the falsified product to unsuspecting patients.

Healthcare providers and the general public should notify the nearest NAFDAC office of any information concerning the distribution, sale and use of the falsified Augmentin product.

SIGNED MANAGEMENT

NAFDAC...........Safeguarding the health of the Nation!!!

           

Read 4294 times Last modified on Thursday, 12 April 2018 14:05
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