NAFDAC investigates substandard Deekins Amoxicillin 500mg capsules

NIGERIA—The National Agency for Food and Drug Administration and Control (NAFDAC) has launched an investigation into the Deekins Amoxicillin 500mg capsules following alarming reports of adverse reactions among users.

 The product has been flagged as potentially substandard and unsafe, raising serious public health concerns. 

This investigation comes just weeks after NAFDAC warned about counterfeit Combiart Dispersible Tablets, an antimalarial drug found in Abuja and Rivers State during routine inspections. 

NAFDAC initiated the probe into the Deekins capsules after receiving reports of severe drug reactions.

Laboratory analysis of the product is underway, and both the manufacturer, Ecomed Pharma Limited, and the marketer, Divine King Pharmaceutical Limited, are under scrutiny.

The agency has also summoned Ecomed’s Quality Control and Production Managers for further questioning.

Additionally, the Pharmacy Council of Nigeria and the pharmacist responsible for the manufacturing site have been informed of the investigation. 

NAFDAC had previously raised concerns about the Deekins Amoxicillin 500mg capsules, specifically those from batch number 4C639001.

Following numerous complaints from users, Ecomed Pharma Limited recalled the batch after an undisclosed hospital reported three cases of severe drug reactions linked to the capsules. 

NAFDAC found discrepancies in the statements issued by the manufacturer and marketer regarding the recalled products.

Ecomed Pharma Limited claimed it only produced 20 packets of batch 4C639001 for registration purposes, while Divine King Pharmaceutical Limited asserted that Ecomed manufactured all recalled products.

Adding to the confusion, NAFDAC discovered that 790 packets of the same batch, with a manufacturing date of March 2024 and an expiry date of February 2027, had been distributed.

Ecomed maintains it only produced 1,961 packets under a different batch number, 4C639002. 

NAFDAC is now analyzing the product to confirm its quality and identify those responsible for the issue.

While the investigation continues, the agency has strongly advised health workers to stop dispensing the capsules and urged the public to avoid their use.  

Distributors have also been warned to refrain from selling the affected batch. NAFDAC emphasized the importance of sourcing medicines only from licensed suppliers and urged anyone possessing the product to return it to the nearest NAFDAC office immediately. 

Patients who have experienced adverse reactions after using the capsules are encouraged to seek medical attention promptly.

The agency also reiterated that adverse drug reactions can be life-threatening, leading to hospitalization, long-term disability, or even death.

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