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Recall Observatory FDA recall evidence

Food product

BTREX PLUS, Dietary Supplement 100 Caplets

F-0484-2021

April 20, 2021

Class III

Product summary

Firm
Lopez Gonzalez Santana Corporation
Event
Event 87758
Status
Terminated
Classification
Class III
Quantity
311 Bottles
Official record key
food-enforcement:F-0484-2021

Official wording

Reason: cGMP Deviation: Presence of damaged tablets

Code information: Lot # 33277 Exp date:12/22

Distribution pattern: Domestic distribution only-PR

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviation