NAFDAC Alerts Nigerians On Recall Of Mivacron, Nimbex Injections
The regulatory agency said the recall followed safety concerns flagged by the Hong Kong Department of Health.
The National Agency for Food and Drug Administration and Control has alerted Nigerians on the recall of Mivacron and Nimbex injections over safety concerns.
In a statement via X on Monday, the regulatory agency said the affected products were manufactured by Aspen Pharmacare Asia Limited, saying the recall followed safety concerns flagged by the Hong Kong Department of Health.
NAFDAC said one batch of Mivacron Injection 0.2 per cent and five batches of Nimbex Injection 2mg/mL are affected by the recall.
“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, adding that “not all glass particles in the ampoules were likely detected,” prompting a voluntary market recall.
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The injections, containing mivacurium and cisatracurium, are prescription medicines used as adjuncts to general anaesthesia.
NAFDAC advised healthcare professionals and consumers to report suspected substandard medicines to its nearest office or via its e-reporting platforms (www.nafdac.gov.ng).
In another development, NAFDAC reassured Nigerians that all Nestlé infant formulae approved for sale in Nigeria are safe.
It stated that the infant formulae were not affected by the recent voluntary recall announced by Nestlé UK involving specific batches of SMA Infant Formula and Follow-On Formula in over 50 countries.
“NAFDAC clarifies that the recalled products are UK batches withdrawn as a precaution due to the potential presence of cereulide, a heat-resistant toxin produced by certain strains of Bacillus cereus, which may cause nausea and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 affected batches were not registered by NAFDAC and are not authorised for distribution in Nigeria,” it said in a statement signed by its Director-General, Mojisola Adeyeye, on Monday.
The agency 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).
