Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PE
Summary
The FDA issued a Class II for Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elem by Monarch PCM, LLC. Reason: Stability is out of spec at 81% for 3 month time period..
Details
Source
Food Recall
External ID
F-1020-2021
Action Date
2021-10-06
Status
Terminated
Category
food
Product Description
Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
Lot/Code Info: Finished Product Lot # 21FP1658
Quantity Affected: 5,495 units
Reason for Recall
Stability is out of spec at 81% for 3 month time period.
Distribution
UT
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
Fort Worth, TX
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 43 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Monarch PCM, LLC has 5 FDA actions in our database, including 5 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 (Monarch PCM, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Monarch PCM, LLC have FDA actions?
Monarch PCM, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1020-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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