The National Agency for Food and Drug Administration and Control, NAFDAC, has alerted the public to the recall of Mivacron and Nimbex injections over safety concerns.
NAFDAC, in a statement on its X handle on Monday, said the products were manufactured by Aspen Pharmacare Asia Limited adding that the recall followed safety concerns approved by the Hong Kong Department of Health.
According to the agency, one batch of Mivacron Injection 0.2 per cent and five batches of Nimbex Injection 2mg/mL were affected.
“The recall was made as a precautionary measure due to potential quality issues identified by the manufacturer,” NAFDAC said.
It said investigations revealed deficiencies in the manufacturer’s manual visual inspection process.
NAFDAC added that “not all glass particles in the ampoules were likely detected,” prompting a voluntary market recall.
The injections, containing mivacurium and cisatracurium, are prescription medicines used as adjuncts to general anaesthesia.
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NAFDAC advised healthcare professionals and consumers to report suspected substandard medicines to its nearest office or via its e-reporting platforms.
The advisory reads in full:
The National Agency for Food and Drug Administration and Control (NAFDAC) is warning the public about the recall of Mivacron injection 0.2% and Nimbex injection 2mg/ml due to safety concerns.
The Hong Kong Department of Health approved the recall of one batch of Mivacron Injection 0.2% (batch no: XPC19) and five (5) batches of Nimbex Injection 2mg/mL (batch no: XP1SQ, XPC1G, XPC6W, XP1V5, and XP1VF), produced by Aspen Pharmacare Asia Limited, over safety concerns. The recall was made as a precautionary measure due to potential quality issues identified by the manufacturer, GlaxoSmithKline.
An investigation conducted by the manufacturer of the products found deficiencies in the manual visual inspection process. The investigation indicated that not all glass particles in the ampoules were likely detected during the inspection of the affected batches. As a precautionary measure, Aspen has decided to voluntarily recall these batches of the two products from the market.
The Mivacron Injection 0.2%, containing mivacurium, and Nimbex Injection 2mg/mL, containing cisatracurium, are prescription medicines used as an adjunct to general anesthesia.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
NAN
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