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Public Alert No. 0009/2019 – Alert on Falsified Hydrochlorothiazide 50mg (Containing Glibenclamide) Circulating in Cameroon

The National Agency for Food and Drug Administration and Control (NAFDAC) alerts the public, especially the health care providers on the circulation of confirmed falsified Hydrochlorothiazide 50mg tablets in Cameroon. The falsified product has been found to contain Glibenclamide instead of Hydrochlorothiazide.

In March 2019, the World Health Organization (WHO) was informed by a nongovernmental organization in Cameroon that a medicine presenting as Hydrochlorothiazide 50mg tablets had caused hypoglycaemia in patients. Confirmatory laboratory analysis has established that the product did not contain  Hydrochlorothiazide, the stated active ingredient. Glibenclamide was instead identified.

Genuine Hydrochlorothiazide is used as an antihypertensive and diuretic medicine, whereas Glibenclamide is an antidiabetic medicine.

The falsified medicine presents a risk for patients who are taking Hydrochlorothiazide for the treatment of hypertension.

The label on the plastic container of this falsified product states Laboratoires Sterop as the manufacturer. However, this company has confirmed to the World Health Organization that it did not manufacture or supply the falsified product.

The Falsified hydrochlorothiazide 50mg is presented in plastic containers of 1000 tablets each.

The batch number, as well as a number of other features shown on the label of the falsified Hydrochlorothiazide 50mg tablets do not correspond to genuine manufacturing records. The label is English and French languages.

The details of the falsified Hydrochlorothiazide 50mg tablets are:

Product Name Hydrochlorothiazide 50mg
 Product Pack 1000 COMPRIMES
Stated manufacturer                             Laboratoires Sterop
Batch Number 16G04
Manufacturing Date 06/2017
Expiry Date 30/05/2021

NAFDAC implores all importers, wholesalers, and retailers not to illegally import, distribute and sell the falsified Hydrochlorothiazide 50mg tablets.

Surveillance has been strengthened by NAFDAC at all ports of entry to prevent importation of the falsified Hydrochlorothiazide 50mg tablets from Cameroon. The agency has also heightened surveillance to prevent distribution and sales of the falsified product.

Health care providers and other members of the public are advised to be vigilant and contact the nearest NAFDAC office with any information on the falsified product.

Anybody in possession of the falsified Hydrochlorothiazide 50m tablets should submit it to the nearest NAFDAC office.

Consumers are advised to report adverse events related to the use of medicines to the nearest NAFDAC office, NAFDAC PRASCOR ( 20543 TOLL FREE for all Network ) or via pharmacovigilance@nafdac.gov.ng.

NAFDAC…….……..Safeguarding the health of the nation!!!

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