The National Agency for Food and Drug Administration
and Control (NAFDAC) has issued a recall of certain Mivacron and Nimbex
injections following safety concerns.
In a statement on Monday via X, the agency said the
affected products were manufactured by Aspen Pharmacare Asia Limited. The
recall follows safety alerts from the Hong Kong Department of Health. One batch
of Mivacron Injection 0.2% and five batches of Nimbex Injection 2mg/mL are
included in the precautionary measure.
“The recall was made as a precautionary measure due to
potential quality issues identified by the manufacturer,” NAFDAC said.
Investigations revealed deficiencies in the manufacturer’s visual inspection
process, meaning that “not all glass particles in the ampoules were likely
detected,” prompting a voluntary market recall.
Mivacron and Nimbex, containing mivacurium and
cisatracurium respectively, are prescription medicines used as adjuncts to
general anaesthesia. NAFDAC advised healthcare professionals and consumers to
report any suspected substandard products via its offices or e-reporting
platforms at www.nafdac.gov.ng.
In a separate clarification, NAFDAC reassured
Nigerians that all Nestlé infant formulae approved for sale in the country
remain safe. The agency stated that the recent voluntary recall by Nestlé UK,
which involved certain batches of SMA Infant Formula and Follow-On Formula in
over 50 countries, does not affect products marketed in Nigeria.
“NAFDAC clarifies that the recalled UK batches were
withdrawn as a precaution due to the potential presence of cereulide, a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 are not registered with NAFDAC and are
not authorised for distribution in Nigeria,” the statement said.
The agency confirmed that the SMA range available in
Nigeria is produced at Nestlé’s Tuas Factory in Singapore and is duly
registered with NAFDAC, including SMA GOLD 1 (Reg. No. B1-2783), SMA GOLD 2
(Reg. No. B1-2780), and SMA GOLD 3 (Reg. No. B1-2781).
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