Nigerians have been warned by the National Agency for Food and Drug Administration and Control (NAFDAC) not to consume or distribute infant formula supplied by Able Groupe, a US-based firm.
The company’s infant formulae were found to have insufficient iron levels and did not meet other FDA criteria US Food and Drug Administration (US-FDA).
Prof. Moji Adeyeye, the NAFDAC Director-General, revealed that the agency had received information from the US Food and Drug Administration about the recall of specific infant formula.
She stated the recalled products were sold under the brand names HiPP, Holle, Bioland, and Kendamil, and that they were recalled because the FDA had not received the requisite pre-market notifications for these new infant formula.
HiPP Comfort Milk formula, HiPP Dutch Stage 1 Combiotic newborn milk formula, and HiPP HA Germany hypoallergenic stage pre combiotic infant milk formula were among the Able Groupe’s goods identified by Adeyeye.
Holle Bio Stage 1 organic newborn 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 are also available.
She stated that the products had less than one milligram of iron per 100 calories and that the eight infant formula product labels lacked the needed ingredient, as well as not being labeled as required by Title 21 of the Code of Federal Regulations (21 CFR 107.10 and 107.20).
Adeyeye said that 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 may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight.
Similarly, they may also not be suitable for those who have low iron levels at birth, or those who are at risk for becoming iron deficient due to illness.
She explained that inadequate intake of iron at infancy may lead to anaemia, iron deficiency which, if untreated, has irreversible cognitive and functional development outcomes.
“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.
“NAFDAC implores importers, distributors, retailers and consumers, who have these products in storage to stop distribution, sale and use of these recalled products.
“NAFDAC encourages consumers and health care professionals to report adverse events related to the use of these recalled products to the nearest NAFDAC office,” she said.
Any concern with these infant formulae should be reported to NAFDAC PRASCOR (20543 TOLL-FREE from all networks), [email protected], or the NAFDAC Med Safety Mobile App.