FDA-Food2021-08-25Class I

HiPP Dutch Stage 1 Combiotic Infant Milk Formula

Able Groupe Inc
Hazard

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some 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, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

Sold states
All sales are direct from firm website - littlebundle.com
Affected count
76,000 units total
Manufactured in
1486 Kleppe Ln, N/A, Sparks, NV, United States
Products
HiPP Dutch Stage 1 Combiotic Infant Milk Formula

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0909-2021

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