Skip to content
Recall Observatory FDA recall evidence

Food product

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

F-0540-2021

July 13, 2020

Class III

Product summary

Firm
Lopez Gonzalez Santana Corporation
Event
Event 87759
Status
Terminated
Classification
Class III
Quantity
lots #32179  1405 and Lot #33278 - 0.
Official record key
food-enforcement:F-0540-2021

Official wording

Reason: CGMP Deviations: Presence of damaged tablets

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

Distribution pattern: Domestic distribution only-PR

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations