Summary
The FDA issued a Class II for HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula by Able Groupe Inc. 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 .
Details
Source
Food Recall
External ID
F-0925-2021
Action Date
2021-08-25
Status
Terminated
Category
food
Product Description
HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
Lot/Code Info: All codes
Quantity Affected: 76,000 units total
Reason for Recall
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.
Distribution
All sales are direct from firm website - littlebundle.com
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-08
Company
Sparks, NV
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 48 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Able Groupe Inc has 21 FDA actions in our database, including 21 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Able Groupe Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Able Groupe Inc have FDA actions?
Able Groupe Inc has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0925-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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