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Recall Observatory FDA recall evidence

Food product

BTI Lean Formula, 400cc HDPE Bottle

F-2265-2014

July 03, 2014

Class II

Product summary

Firm
GM Manufacturing Inc.
Event
Event 68717
Status
Terminated
Classification
Class II
Quantity
1,000 units
Official record key
food-enforcement:F-2265-2014

Official wording

Reason: GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.

Code information: LT7345 EX10.16

Distribution pattern: CA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    violations of the cGMP