Summary
The FDA issued a Class I for Holle Bio Stage 1 Organic 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. Some products contain less than 1 milligram o.
Details
Source
Food Recall
External ID
F-0916-2021
Action Date
2021-08-25
Status
Terminated
Category
food
Product Description
Holle Bio Stage 1 Organic 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. 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
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 I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-0916-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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