Food product
Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
F-0921-2021
Product summary
- Firm
- Able Groupe Inc
- Event
- Event 88432
- Status
- Terminated
- Classification
- Class I
- Quantity
- 76,000 units total
- Official record key
food-enforcement:F-0921-2021
Official wording
Reason: 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.
Code information: All codes
Distribution pattern: All sales are direct from firm website - littlebundle.com
Derived failure modes
-
Unknown
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.