Food recall

Premier Research Labs LP recall: Quantum Gallbladder Support

Premier Research Labs LP, of Austin, TX, recalled Quantum Gallbladder Support and 1 other product. The FDA's reason: “Undeclared wheat.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on October 22, 2014, and the FDA first listed it in its Enforcement Report of December 10, 2014. 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

Allergen not on the label

Status

Terminated

Closed March 2, 2017

The recall

Company
Premier Research Labs LP (Austin, TX)
Reason, in FDA's words
“Undeclared wheat”
Where it was sold
Gallbladder Support products were distributed in all states in the US as well as internationally to Canada, Ecuador, and Singapore. BiliVen products were distributed in all states in the US as well as internationally to Canada, Hong Kong, Ireland, New Zealand, Singapore, United Arab Emirates, United Kingdom, Australia, Bermuda, Fiji, and Israel.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
69561

The 2 products recalled

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

  • F-0591-2015 Class II

    Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411

    Codes: Lot Number: 111202-12411, 130411-12411, 130612-12411, 130708-12411

    Quantity: 7101 bottles

  • F-0592-2015 Class II

    Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411

    Codes: Lot Number: 111202-2411, 130411-2411, 130612-2411, 130708-2411; UPC 0773502411

    Quantity: 49,830 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 December 10, 2014.

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.