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Recall Observatory FDA recall evidence

Food product

Therapeutic Care A, B, C, 225cc HDPE Bottles for A,B. Capsules for C

F-2268-2014

July 03, 2014

Class II

Product summary

Firm
GM Manufacturing Inc.
Event
Event 68717
Status
Terminated
Classification
Class II
Quantity
168,874 units
Official record key
food-enforcement:F-2268-2014

Official wording

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

Code information: LOTKZ1350, EXP11/2016 LOT KZ1351, EXP11/2016 LOTKZ1352, EXP11/2016

Distribution pattern: CA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    violations of the cGMP