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Recall Observatory FDA recall evidence

Food product

HiPP AR Germany Anti-Reflux Milk Formula

F-0908-2021

August 08, 2021

Class II

Product summary

Firm
Able Groupe Inc
Event
Event 88432
Status
Terminated
Classification
Class II
Quantity
76,000 units total
Official record key
food-enforcement:F-0908-2021

Official wording

Reason: The required pre-market notifications for these new infant formulas have not been submitted to the FDA. 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

    reason.no_named_rule · v1.0.0

    The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.