NAFDAC Recalls Mivacron and Nimbex Injections Over Safety Concerns

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The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an alert to Nigerians regarding the recall of Mivacron and Nimbex injections due to potential safety risks.

In a post on its X handle on Monday, the agency stated that the affected products were manufactured by Aspen Pharmacare Asia Limited. The recall follows safety concerns highlighted by the Hong Kong Department of Health.

NAFDAC confirmed that one batch of Mivacron Injection 0.2 per cent and five batches of Nimbex Injection 2mg/mL are impacted by the precautionary recall. The agency explained that the decision was taken because of potential quality issues identified by the manufacturer, including deficiencies in the manual visual inspection process, which may have failed to detect all glass particles in some ampoules.

Both injections, which contain mivacurium and cisatracurium, are prescription medicines used as adjuncts to general anaesthesia. The agency stressed that the recall is voluntary and preventive, aimed at safeguarding patients and healthcare providers.

NAFDAC further urged healthcare professionals and members of the public to report any suspected substandard or unsafe medicines to its offices nationwide or via its e-reporting platforms.

The agency reiterated its commitment to ensuring the safety, efficacy, and quality of medicines in circulation, emphasizing that patient safety remains its top priority. Consumers and hospitals in possession of the affected batches have been advised to return them immediately to the point of purchase or relevant regulatory authorities.

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