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Public Alert No: 0016/2019 – Alert on Falsified Augmentin Products Circulating in Uganda and Kenya

September 5, 2019,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified by the World Health Organisation (WHO) on the circulation of confirmed falsified Augmentin (Amoxicillin trihydrate + Potassium clavulanate) in Uganda and Kenya. In April 2018, NAFDAC  received a similar alert from WHO on falsified Augmentin circulating in Cameroun. This alert was communicated to the Nigerian public in Public Alert No: 0007/2018 – Falsified Augmentin Products Circulating in Cameroun

Amoxycillin + Clavulanic acid is used to treat a range of bacterial infections and is on WHO Essential Medicines list.

The National Drug Authority (NDA), Uganda informed WHO that the falsified Augmentin was detected at patient level in Uganda through routine post marketing surveillance on the quality of medical products. Samples of the falsified Augmentin were submitted to laboratory for quality testing and the result revealed none of the expected active ingredients.

The Pharmacy and Poisons Board (PPB), Kenya confirmed to WHO that the same batch of the falsified Augmentin had previously been found at patient level in Kenya.

The falsified Augmentin has labelling and packaging inconsistencies. The stated manufacturer, SmithKline Beecham Limited has confirmed they did not manufacture this falsified version.

No known adverse reactions to this product have been reported.

The details of the falsified Augmentin (Amoxicillin trihydrate + Potassium clavulanate) are:

Product Name Augmentin (Amoxicillintrihydrate + Potassium

clavulanate)

Stated Manufacturer SmithKline Beecham Limited
Batch Number 786627
Manufacturing Date Aug 2016
Expiry Date Aug 2019
Stated Active Ingredients 500 mg amoxicillin as amoxicillin trihydrate Ph.Eur
125 mg clavulanic acid as potassium clavulanate Ph.Eur.

NAFDAC has strengthened surveillance at all ports of entry to prevent the importation of the falsified Augmentin into Nigeria.

Healthcare providers and other members of the public are implored to contact the nearest NAFDAC office with any information concerning the distribution, sale and use of the falsified Augmentin.

Consumers are advised to report adverse events related to the use of medicines and medical product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), pharmacovigilance@nafdac.gov.ng or via the eReporting platform available on the NAFDAC Website www.nafdac.gov.ng

NAFDAC……Safeguarding the health of the Nation!!!

Signed Management