Summary
The FDA issued a Class I for Moor Herbs Healthy Beauty Angel Formula packed in 16oz. plastic containers by MOOR HERBS. Reason: Product is marketed as an infant formula but the required pre-market infant formula notification for this product has not been submitted to the FDA. .
Details
Source
Food Recall
External ID
F-0519-2022
Action Date
2022-01-19
Status
Terminated
Category
food
Product Description
Moor Herbs Healthy Beauty Angel Formula packed in 16oz. plastic containers
Lot/Code Info: All products. Product does not have any lot code information.
Quantity Affected: 147 units
Reason for Recall
Product is marketed as an infant formula but the required pre-market infant formula notification for this product has not been submitted to the FDA. Product tested by FDA was well above the maximum acceptable range for Iron, Potassium and Sodium, which could potentially lead to iron overload and/or electrolyte imbalances. In addition, the product did not have vitamin D, and a vitamin D deficiency can potentially lead to rickets, a softening and weakening of bones.
Distribution
Products were distributed via internet sales and through the firm's store-front.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-23
Company
Detroit, MI
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 146 food recalls issued in the same week, part of 204 food-related FDA actions this month.
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 (MOOR HERBS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MOOR HERBS have FDA actions?
This is the only FDA action we have on record for MOOR HERBS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0519-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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