The National Agency for Food and Drug Administration and Control (NAFDAC) has warned the public about the recall of specific batches of Mivacron Injection 0.2% and Nimbex Injection 2mg/mL due to potential safety hazards.
The Hong Kong Department of Health authorised the recall of one batch of Mivacron (batch no: XPC19) and five batches of Nimbex (batch nos: XP1SQ, XPC1G, XPC6W, XP1V5, XP1VF), manufactured by Aspen Pharmacare Asia Limited.
GlaxoSmithKline identified quality issues in the manual visual inspection process, where glass particles in ampoules may have gone undetected.
Aspen initiated a voluntary recall as a preventive step to protect patients, since both drugs, Mivacron (mivacurium) and Nimbex (cisatracurium), serve as adjuncts to general anaesthesia in surgical settings.
No adverse events have been confirmed yet, but healthcare providers and users should immediately quarantine affected batches.
NAFDAC urged reporting of substandard or falsified products to its offices, via toll-free line 0800-162-3322, or email at [email protected].
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