The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 44/2025, warning the public about the recall of Mivacron Injection 0.2% and Nimbex Injection 2mg/ml due to safety concerns.
According to the agency, the recall follows approval by the Hong Kong Department of Health for the withdrawal of one batch of Mivacron Injection 0.2% (batch number XPC19) and five batches of Nimbex Injection 2mg/ml (batch numbers XP1SQ, XPC1G, XPC6W, XP1V5 and XP1VF). The affected products were manufactured by Aspen Pharmacare Asia Limited.
NAFDAC explained that the recall was initiated as a precautionary measure after potential quality issues were identified by the manufacturer, GlaxoSmithKline. An investigation revealed deficiencies in the manual visual inspection process, raising concerns that not all glass particles in the ampoules may have been detected during inspection of the affected batches.
As a result, Aspen Pharmacare Asia Limited voluntarily recalled the identified batches from the market to safeguard public health.
Mivacron Injection 0.2%, which contains mivacurium, and Nimbex Injection 2mg/ml, containing cisatracurium, are prescription-only medicines commonly used as adjuncts to general anaesthesia.
NAFDAC advised healthcare professionals and members of the public to remain vigilant and report any suspected sale of substandard or falsified medicines or medical devices to the nearest NAFDAC office. Reports can also be made by calling 0800-162-3322 or via email at sf.alert@nafdac.gov.ng
