Food recall

Lopez Gonzalez Santana Corporation recall: BTREX PLUS, Dietary Supplement 2 Caplets

Lopez Gonzalez Santana Corporation, of Rio Piedras, PR, recalled BTREX PLUS, Dietary Supplement 2 Caplets and 1 other product. The FDA's reason: “CGMP Deviations: Presence of damaged tablets.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on July 13, 2020, and the FDA first listed it in its Enforcement Report of May 26, 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 III

It is unlikely to cause harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed October 8, 2021

The recall

Company
Lopez Gonzalez Santana Corporation (Rio Piedras, PR)
Reason, in FDA's words
“CGMP Deviations: Presence of damaged tablets”
Where it was sold
Domestic distribution only-PR
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
87759

The 2 products recalled

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

  • F-0540-2021 Class III

    BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)

    Codes: Lot# 32179, Exp. 9/2022 Lot# 33278, Exp. 12/2022

    Quantity: lots #32179  1405 and Lot #33278 - 0.

  • F-0541-2021 Class III

    BTREX PLUS, Dietary Supplement 100 Caplets

    Codes: Lot # 33491, Exp. 12/22

    Quantity: 662 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 May 26, 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.