F-0907-2021 Class I Terminated
Recall Details
- Product Type
- Food
- Report Date
- August 25, 2021
- Initiation Date
- August 8, 2021
- Termination Date
- September 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76,000 units total
Product Description
HiPP Comfort Milk Formula
Reason for Recall
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.
Distribution Pattern
All sales are direct from firm website - littlebundle.com
Code Information
All codes.