The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert warning Nigerians about the circulation of a counterfeit batch of Artemether/Lumefantrine tablets, falsely branded as Aflotin 20/120, in the Nigerian market.

According to the agency on its official X account, the discovery was made following a report by Ajanta Pharma Limited, a pharmaceutical company based in Mumbai, India, which is the genuine manufacturer of the original product.

The company informed the agency that a falsified version of its anti-malarial medication had surfaced in Nigeria, bearing the batch number PA2128L.

Ajanta Pharma reportedly clarified that this specific batch was originally manufactured in December 2018 and expired in November 2020 under the brand Combisunate 20/120 with a pack size of 30 x 24 tablets. However, the falsified version is being sold under the name Aflotin 20/120mg, repackaged in a different format (1 x 18 tablets).

The company further explained that the counterfeit product failed to match its approved packaging standards. ?The overprinted matter on the falsified tablets did not align with Ajanta?s printing style, and the carton?s artwork was inconsistent with our approved design,? the company stated.

Ajanta Pharma confirmed that it had not manufactured the Aflotin 20/120mg bearing Batch No: PA2128L and that the product currently in circulation with that batch number is counterfeit, based on its investigation.

NAFDAC emphasised the health risks posed by counterfeit medicines, stating that such products may not comply with regulatory standards, putting consumers at risk of ineffective treatment and severe health consequences, including death.

According to NAFDAC, the genuine Aflotin 20/120 is a combination therapy of Artemether (20mg) and Lumefantrine (120mg), used to treat uncomplicated malaria caused by the Plasmodium falciparum parasite.

The agency reported that the counterfeit version in circulation is labelled with a manufacturing date of April 2023 and an expiry date of March 2026. The packaging falsely attributes manufacturing to Ajanta Pharma Limited, with its stated address in Mumbai, India.

In response to the alert, NAFDAC has directed all zonal directors and state coordinators to intensify surveillance efforts and remove any counterfeit products found within their jurisdictions.

The agency also urged distributors, retailers, healthcare professionals, and caregivers to exercise caution and ensure that all medical products are sourced from authorised and licensed suppliers.

NAFDAC advised healthcare providers and consumers to report any suspicious or substandard medicines to the nearest NAFDAC office or through its e-reporting platforms. Reports of adverse drug reactions or side effects are also encouraged through the same channels. (The Guardian)

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