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FDA · Food recall

Btrex Plus… and 1 more product

May 26, 2021 Class III

Date
May 26, 2021
Risk class
Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
Status
Terminated
Filed by
Lopez Gonzalez Santana Corporation
Reason
CGMP Deviations: Presence of damaged tablets
Distribution pattern
Domestic distribution only-PR

2 products in this recall

Btrex Plus…

Product
BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
Quantity
lots #32179  1405 and Lot #33278 - 0.
Codes and lots
Lot# 32179, Exp. 9/2022 Lot# 33278, Exp. 12/2022
Recall started
July 13, 2020
Recall number
F-0540-2021

Btrex Plus…

Product
BTREX PLUS, Dietary Supplement 100 Caplets
Quantity
662 bottles.
Codes and lots
Lot # 33491, Exp. 12/22
Recall started
July 13, 2020
Recall number
F-0541-2021

What should I do? Food recall: what to do with it

Source: FDA · Food enforcement reports, recall numbers F-0540-2021, F-0541-2021. The agency record governs; check it and the company before acting.

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