NAFDAC investigates substandard amoxicillin product over safety concerns

The National Agency for Food and Drugs Administration and Control (NAFDAC) has commenced investigation of the Deekins Amoxicillin 500mg Capsule, a product reported to be substandard and unsafe for use.

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The agency said it decided to investigate after receiving disturbing reports of patients experiencing severe reactions after using the capsule.

In a statement issued on Thursday, the agency said the products have been sampled for laboratory analysis, and the manufacturer, Ecomed Pharma Limited, and its marketer, Divine King Pharmaceutical Limited, are being interrogated.

The agency also said: “The Quality Control and Production Managers have been invited for further investigation. The Pharmacy Council of Nigeria, the agency that issued the site license for the site, and the pharmacist in charge have been notified.”

Previous warning

NAFDAC had earlier raised an alarm about the Deekins Amoxicillin 500mg capsules with batch number 4C639001 over safety concerns.

The agency had warned against using the Deekins Amoxicillin 500mg capsules due to their adverse effects on users, noting that the manufacturing company, Ecomed Pharma Limited, had recalled the product after multiple reports from users.

NAFDAC said the manufacturer recalled after an unidentified hospital reported three cases concerning drug reactions linked to the product.

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The agency said: “This drug batch is being recalled following reports of severe adverse drug reactions.

“According to Ecomed Pharma Ltd, reports of serious adverse drug reactions were received from a hospital that reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxicillin 500mg capsule”.

Contradictory statement

Both the manufacturing and marketing companies have both issued statements on the Deekins Amoxycillin 500mg Capsule.

According to NADFAC, the statements from the companies are contradictory.

NAFDAC said Ecomed Pharma Limited claimed to have produced less than the quantity of the affected products marketed and sold to the public.

For the substandard drug, which has 4C639001 as its batch number, the manufacturing company said it only produced 20 packets, which were to be used to renew its registration.

The company claimed to have produced another drug with a different batch number in a larger quantity.

“However, Seven Hundred and Ninety (790) packs of Batch 4C639001 with manufacturing 03/2024 and Expiry Date 02/2027 were recalled, which he did not manufacture,” the agency said.

“He claimed to have manufactured One Thousand, Nine Hundred and Sixty-One (1,961) packets, Batch No 4C639002.”

However, the marketing company, Divine King Pharmaceutical Limited, has argued that Ecomed Pharma Limited manufactured all the recalled products.

NAFDAC said: “In the statement obtained from Mr Kingsley Ekeanyanwu, the Marketing Authorization Holder (MAH), capsule, Divine King Pharmaceutical Limited, stated that all products were manufactured by Ecomed Pharma Limited.

“The products have been sampled for laboratory analysis against the suspects, Pharm Ekene Christopher, Ecomed Pharma Ltd and Mr Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Ltd. The analysis is currently pending determination while the investigation is ongoing”.

READ ALSO: NAFDAC warns against use of amoxicillin product over safety concerns

Warning

The agency reiterated its warning against the use of the drug, noting that adverse drug reactions can be life-threatening, leading to hospitalisation, significant disability, or even death.

It warned health workers against dispensing the Deekin Amoxicillin capsule and the public against usage.

The agency also implored distributors within the supply chain to avoid distributing, administering, or selling the affected product.

It said: “The affected lots of the product. All medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

“Anyone possessing the affected lot is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office. If you have used this product, or someone you know, has used it, or suffered any adverse reaction/event after use, are advised to seek immediate medical advice from a qualified healthcare professional.”