NAFDAC officials
The manufacturer of the recalled batch of Deekins Amoxycilin 500mg capsule is in custody, says the National Agency for Food and Drugs Administration and Control (NAFDAC).
Prof. Mojisola Adeyeye, the Director-General of the agency, confirmed this on Tuesday at a news conference in Lagos.
On Dec. 11, NAFDAC notified the public of the recall of one batch of Deekins Amoxycillin 500mg capsule.
The product was allegedly manufactured by Ecomed Pharma Ltd. and allegedly marketed by DevineKings Pharmaceutical Ltd., with lot number 4C639001.
The drug batch was recalled following reports of allegedly serious adverse drug reactions received from a hospital that reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg capsule.
Amoxicillin is a penicillin antibiotic indicated for treating bacterial infections such as tonsillitis, bronchitis, sinusitis, pneumonia, and bacterial infections of the ear, nose, throat, skin, or urinary tract.
Adeyeye said: “The producer of the drug gave another company to contract the manufacturing for them and there’s nothing wrong with that but the contracted manufacturer was already in trouble.
“We’ve already shut the company down, before you agree to do contract manufacturing for somebody, we must know.
“Before you go to a company to do contract manufacturing for you, you must tell us. Neither of them told us, so we shut them down.
“Deekins Amoxicillin has been tied to that contract manufacturer, so we invited them to our office where the contract manufacturer said, they just manufactured samples for registration.
“Manufacturers are expected to show some samples before manufacturing but the spread of the product is more than a few packets that they claimed to have manufactured.
“The manufacturer is already in custody, the drugs are still being tested in the laboratory to know what is inside and to determine if there will be more charges against the person.”
Adeyeye reiterated NAFDAC’s commitment to protecting public health and ensuring that only safe, effective, and scientifically supported products are approved. (NAN)
