Recall · openFDA Food Enforcement

BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802…: FDA Recall F-0540-2021

Agency action: Jul 13, 2020Record ID: F-0540-2021
View official source ↗

What happened

Original notice title

BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples), recall F-0540-2021

From the archived source record

CGMP Deviations: Presence of damaged tablets

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Terminated
FDA recall classification
Class III
Recall initiated by
Voluntary: Firm initiated
Report date
May 26, 2021
Termination date in the archive
Oct 8, 2021
Source checked
Jul 16, 2026
Record revision
67845d1f4508

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
Company
Lopez Gonzalez Santana Corporation
Lot / identifier
Lot# 32179, Exp. 9/2022 Lot# 33278, Exp. 12/2022
Market / distribution
Domestic distribution only-PR