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.
The infant formulas from the company were said to have insufficient iron levels and did not meet up with other requirements of the US Food and Drug Administration (US-FDA).
A statement issued by the NAFDAC Director General, Prof. Moji Adeyeye, disclosed that the agency had received information from the US-FDA on the recall of certain infant Formulas.
She said that the recalled products were sold under the brand names HiPP, Holle, Bioland and Kendamil, adding that they were recalled because the required pre-market notifications for these new infant formulas had not been submitted to the FDA.
Adeyeye identified the 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 said that the products contained less than one milligram of iron per 100 calories, and that the eight infant formula product labels failed to have the required ingredient, including not being labelled as required by Code of Federal Regulations Title 21 (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.
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.
NAN
