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Recall Observatory FDA recall evidence

Food product

BTREX PLUS, Dietary Supplement 100 Caplets

F-0541-2021

July 13, 2020

Class III

Product summary

Firm
Lopez Gonzalez Santana Corporation
Event
Event 87759
Status
Terminated
Classification
Class III
Quantity
662 bottles.
Official record key
food-enforcement:F-0541-2021

Official wording

Reason: CGMP Deviations: Presence of damaged tablets

Code information: Lot # 33491, Exp. 12/22

Distribution pattern: Domestic distribution only-PR

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations