Food recall

Monarch PCM, LLC recall: Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz

Monarch PCM, LLC, of Fort Worth, TX, recalled Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. The FDA's reason: “Stability is out of spec at 81% for 3 month time period.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on September 2, 2021, and the FDA first listed it in its Enforcement Report of October 6, 2021. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

See FDA's words below

Status

Terminated

Closed November 22, 2023

The recall

Company
Monarch PCM, LLC (Fort Worth, TX)
Reason, in FDA's words
“Stability is out of spec at 81% for 3 month time period.”
Where it was sold
UT
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
88597

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1020-2021 Class II

    Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle

    Codes: Finished Product Lot # 21FP1658

    Quantity: 5,495 units

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of October 6, 2021.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.