The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public warning following the recall of Mivacron and Nimbex injections due to safety concerns linked to their production process.
In a statement released on Monday via its official X (formerly Twitter) handle, NAFDAC disclosed that the affected products were manufactured by Aspen Pharmacare Asia Limited. The agency explained that the recall was initiated after safety concerns were raised and approved by the Hong Kong Department of Health, prompting regulatory action.
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According to NAFDAC, the recall affects one batch of Mivacron Injection 0.2 per cent and five batches of Nimbex Injection 2mg/mL. The action, it said, was taken as a precautionary measure following the identification of potential quality defects during internal investigations by the manufacturer.
NAFDAC revealed that the investigation uncovered deficiencies in the company’s manual visual inspection process. As a result, there was a possibility that not all glass particles present in the ampoules were detected before the products were released into the market. This discovery led to a voluntary recall of the affected batches to prevent potential harm to patients.
Mivacron and Nimbex injections contain mivacurium and cisatracurium respectively and are prescription-only medicines commonly used as adjuncts to general anaesthesia during surgical procedures.
The agency urged healthcare professionals, hospitals, and consumers to exercise caution and immediately discontinue the use of the affected products. NAFDAC also advised the public to report any suspected substandard or adverse drug reactions to its nearest office or through its official e-reporting platforms.
NAFDAC reaffirmed its commitment to safeguarding public health and ensuring that only safe, effective, and quality medicines are available in Nigeria.
