Food recall

ProThera, Inc. dba SFI USA recall: Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code

ProThera, Inc. dba SFI USA, of Reno, NV, recalled Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code. The FDA's reason: “Mis-packaging; product is labeled as Reduce L-Glutathione but actually contains Lithium Orotate.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on December 13, 2018, and the FDA first listed it in its Enforcement Report of April 3, 2019. 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

Labeling, packaging or manufacturing problems

Status

Terminated

Closed April 2, 2019

The recall

Company
ProThera, Inc. dba SFI USA (Reno, NV)
Reason, in FDA's words
“Mis-packaging; product is labeled as Reduce L-Glutathione but actually contains Lithium Orotate.”
Where it was sold
US distribution to the following: AL, AZ, CA, KS, LA, MI, MO, NH, NJ, NY, OR, PA, TX, and WA Foreign distribution to the following: Netherlands, Great Britain, and Korea
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
81788

The product recalled

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

  • F-1186-2019 Class II

    Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9

    Codes: FG Lot: 2018210303 Expiration: 05/2020

    Quantity: 139 bottles

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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 April 3, 2019.

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.