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Recall Observatory FDA recall evidence

Food product

BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801

F-0665-2021

May 25, 2021

Class III

Product summary

Firm
Lopez Gonzalez Santana Corporation
Event
Event 88029
Status
Terminated
Classification
Class III
Quantity
894 bottles
Official record key
food-enforcement:F-0665-2021

Official wording

Reason: CGMP Deviations: Presence of damaged tablets

Code information: Lot #30636, 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