The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians to stop consuming and distributing infant formulas manufactured by Able Groupe, a U.S.-based company.
According to NAFDAC, the infant formulas from the company have insufficient iron levels and do not meet other U.S. Food and Drug Administration (US-FDA) requirements.
In a statement issued by its Director-Deneral, Proif. Moji Adeyeye, it noted that the agency received information from the US-FDA on the recall of certain infant formulas.
She further explained that the recalled products were sold under the brand names HiPP, Holle, Bioland, and Kendamil.
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NAFDAC disclosed that the U.S. authorities recalled the products because the required pre-market notifications for the new infant formulas had not been submitted to the FDA.
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Ms Adeyeye identified Able Groupe’s products, to include HiPP comfort milk formula, HiPP Dutch stage 1 Combiotic Infant milk formula, HiPP HA Germany hypoallergenic stage pre combiotic infant milk formula. Also, Holle Bio Stage 1 organic infant milk formula, Holle Bio stage pre organic infant milk formula, Lebenswert Anfangsmilch stage 1 organic infant milk formula, and HiPP UK stage 1 Combiotic first infant milk formula.
She further revealed that the products contained less than one milligram of iron per 100 calories. Also, she stated that the eight infant formula product labels failed to have the required ingredient, including not being labelled as required by the Code of Federal Regulations Title 21 (21 CFR 107.10 and 107.20).
Ms Adeyeye said the recalled products were intended as a complete or partial substitute for human milk for children aged 12 months and below, but by containing less than one milligram (1mg) of iron per 100 calories might not provide adequate iron for some infants, particularly infants born prematurely or with low birth weight.
“Infant formula products that contain less than one milligram of iron per 100 calories are required to include a statement on the label indicating that additional iron may be necessary,” she stated. “NAFDAC implores importers, distributors, retailers and consumers, who have these products in storage to stop distribution, sale, and use of these recalled products.”
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NAFDAC urged consumers and health care professionals to report adverse events related to the use of the recalled products to the “nearest NAFDAC office.”
“The public are also advised to report any issue relating to these infant formulas to NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or NAFDAC Med Safety Mobile App,” said the statement. (NAN)
