Laboratoires Novalac has issued a recall in France
Published:
A dozen illnesses have been reported in France linked to a brand of infant formula.
Eleven reports were received via the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) nutrivigilance system, and one via another system, for adverse digestive effects in infants such as diarrhea and vomiting. All concern the same batch of Allernova AR formula from Laboratoires Novalac.
A voluntary withdrawal and recall of batch 183403 has been undertaken by the company. The powdered formula comes in a 400-gram tub and has a date of July 17, 2028. It was sold at pharmacies in France from April to June 12.
One infant was hospitalized after a stool sample test revealed the presence of adenovirus, a pathogen responsible for gastroenteritis that is not typically transmitted through breast milk.
The manufacturer has also received complaints about the same batch relating to issues such as an unusual color and odor.
No link to cereulide incident
United Pharmaceuticals, the owner of Laboratoires Novalac, conducted enhanced testing on the affected batch manufactured in Germany and shared results with authorities in Paris, where the company’s French headquarters are located.
The organoleptic changes are believed to be because of excessive heating of part of the batch. Analyses carried out by the manufacturer showed no pathogens.
Cereulide toxin, which was behind a recent alert concerning infant formula sold by various companies worldwide, was also not detected.
French officials said the non-conformities make the product unfit for consumption, as its color and odor are unacceptable to consumers, although no conclusions can yet be drawn regarding potential health risks.
The Directorate General for Food (DGAL) is in contact with German authorities to ensure measures deemed necessary for consumer safety are taken. DGAL is handling the case with the Directorate General for Health (DGS), Santé publique France, and experts at ANSES.
Anyone who has any boxes from the affected batch should stop their use and return them to the pharmacy in exchange for a box from another batch.
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