The National Agency for Food and Drug Administration and Control (NAFDAC) received an intelligence report from the Office of the Secretary to the Government of the Federation (OSGF) about the recall of Mivacron injection 0.2% and Nimbex injection 2mg/ml by Hong Kong Department of Health 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), by the Marketing Authorization Holder Aspen Pharmacare Asia Limited, over safety concerns. The recall was made as a precautionary measure due to potential quality issues.
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 Hong Kong 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.
You can open the Hong Kong recall page using the link below:
Product Details
Product name | Marketing Authorization Holder in Hong Kong | Batch No. |
Mivacron Inj. 0.2% | Aspen Pharmacare Asia Limited | XPC19 |
Nimbex Inj. 2mg/mL | Same as above | XP1SQ XPC1G XPC6W XP1V5 XP1VF |
NAFDAC implores healthcare providers and patients to always exercise caution and vigilance within the supply chain to avoid the purchase, sale, administration or use of the recalled product. Avoid the purchase, sale or use of unregistered medical products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
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
NAFDAC………. Customer-focused, Agency-minded!!!
