The National Agency for Food and Drug Administration and Control (NAFDAC) has taken into custody the manufacturer of a batch of Deekins Amoxicillin 500mg capsules that was recently recalled due to safety concerns.
NAFDAC Director-General Mojisola Adeyeye confirmed the development at a news conference in Lagos on Tuesday.
The batch, with lot number 4C639001, was recalled on December 11 after reports of severe adverse drug reactions from a hospital that treated three patients who had taken the medication.
The product was reportedly manufactured by Ecomed Pharma Ltd. and marketed by DevineKings Pharmaceutical Ltd.
Adeyeye explained that the contract manufacturer responsible for producing the drug did not inform NAFDAC before commencing production, leading to the shutdown of the company.
“Before you agree to do contract manufacturing for somebody, we must know. Neither of them told us, so we shut them down,” she said.
While the contract manufacturer initially claimed to have produced only samples for registration, Adeyeye revealed that the distribution of the product exceeded what was originally reported. “The manufacturer is already in custody, and the drugs are still being tested in the laboratory to determine their contents and whether additional charges will be filed,” she added.
The investigation into the matter is ongoing.