WHY THIS PRODUCT IS LISTED
Other / see 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.
Product description & recall reason
The recall record describes “HiPP Comfort Milk Formula”; the source reports: “The required pre-market notifications for these new infant formulas have not been submitted to the FDA.”
Based on the official recall record; packaging and sales claims have not been verified. Verify with the official source ↗
Identify the product
- Product description
- HiPP Comfort Milk Formula
- Brand
- Not supplied by this source
- Lot, batch, UPC & other codes
- All codes.
- Quantity
- 76,000 units total
Where it came from & where it went
- Recalling firm
- Able Groupe Inc
- Recalling firm address
- 1486 Kleppe Ln; N/A; Sparks; NV; 89431-6428; United States
- Product production / origin location
- Not supplied by this source
- Distribution — source wording
- All sales are direct from firm website - littlebundle.com
States identified in the source
No specific states identified in the available distribution text.
State matching is derived from the source’s distribution wording, which may be incomplete. The recalling company’s address is not used as the distribution location.