HiPP; Holle; Bioland; Kendamil · Products labeled as infant formula

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Lotes o códigos

The company identified the products as follows: (iron levels provided after each product name, milligrams per 100 Calories) All lots codes are being recalled.

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Able Groupe retiró este producto. Motivo: Error en la etiqueta.

The recalled products are infant formulas (i.e., products intended as a complete or partial substitute for human milk for children 12 months old and younger), but the required pre-market notifications for these new infant formulas have not been submitted to the FDA. In addition, the HiPP Comfort Milk Formula, HiPP Dutch Stage 1 Combiotic Infant Milk Formula, HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula, HiPP German Stage 1 Combiotic Infant Milk Formula, 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 products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, those who had low iron levels at birth, or those who are at risk for becoming iron deficient due to illness. Inadequate…

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Según el aviso: Furthermore, all of the infant formulas distributed by Able Group are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English. The products were imported from Europe and distributed to consumers in the U.S. via mail services.…

FDA recall announcement: Able Groupe Recalling Products Labeled as Infant Formula Formulas Have Insufficient Iron Levels as Per Requirements for Infant Formula in The U.S., and Products Do Not Meet Other FDA Requirements Company: Able Groupe Product: Products labeled as infant formula (brand: HiPP; Holle; Bioland; Kendamil) Reason: Products do not meet FDA requirements. [Food & Beverage Safety] Distribution: Furthermore, all of the infant formulas distributed by Able Group are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English. The products were imported from Europe and distributed to consumers in the U.S. via mail services. The products were not Codes: The company identified the products as follows: (iron levels provided after each product name, milligrams per 100 Calories) All lots codes are being recalled.