The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to the recall of certain Mivacron and Nimbex injections over safety concerns.
In a statement on X on Monday, the regulatory agency said the affected products were manufactured by Aspen Pharmacare Asia Limited, adding that the recall follows safety concerns flagged by the Hong Kong Department of Health.
NAFDAC said one batch of Mivacron Injection 0.2% and five batches of Nimbex Injection 2mg/mL are subject to the recall.
“The recall was made as a precautionary measure due to potential quality issues identified by the manufacturer,” the agency said. Investigations revealed deficiencies in the manufacturer’s manual visual inspection process, noting that “not all glass particles in the ampoules were likely detected,” which prompted a voluntary market recall.
The injections, containing mivacurium and cisatracurium, are prescription medicines used as adjuncts to general anaesthesia. NAFDAC urged healthcare professionals and consumers to report suspected substandard medicines to the nearest NAFDAC office or via its e-reporting platforms at www.nafdac.gov.ng.
In a separate update, NAFDAC reassured Nigerians that all Nestlé infant formulae approved for sale in Nigeria are safe.
The agency clarified that the recent voluntary recall announced by Nestlé UK, involving specific batches of SMA Infant Formula and Follow-On Formula in over 50 countries, does not affect products sold in Nigeria.
“NAFDAC confirms that the recalled products are UK batches withdrawn as a precaution due to the potential presence of cereulide, a heat-resistant toxin produced by certain strains of Bacillus cereus, which may cause nausea and vomiting. These batches were not registered by NAFDAC and are not authorised for distribution in Nigeria,” the agency said in a statement signed by its Director-General, Mojisola Adeyeye, on Monday.
The agency further confirmed that the SMA range marketed in Nigeria is manufactured at Nestlé’s Tuas Factory in Singapore and is duly registered with NAFDAC, including SMA GOLD 1 (NAFDAC Reg. No. B1-2783), SMA GOLD 2 (NAFDAC Reg. No. B1-2780), and SMA GOLD 3 (NAFDAC Reg. No. B1-2781).
