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Recall Observatory FDA recall evidence

Food product

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

F-0666-2021

May 25, 2021

Class III

Product summary

Firm
Lopez Gonzalez Santana Corporation
Event
Event 88029
Status
Terminated
Classification
Class III
Quantity
4641 units (2 tablet bottles)
Official record key
food-enforcement:F-0666-2021

Official wording

Reason: CGMP Deviations: Presence of damaged tablets

Code information: Lot #30637, Expiration Date 01. 2022

Distribution pattern: Domestic distribution only-PR

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations