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Recall Observatory FDA recall evidence

Drug product

PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.

D-0503-2022

January 24, 2022

Class II

Product summary

Firm
Ultra Seal Corporation
Event
Event 89464
Status
Terminated
Classification
Class II
Quantity
a) 113,040 packets, b) 7,132 bottles
Official record key
drug-enforcement:D-0503-2022

Official wording

Reason: cGMP deviations

Code information: Lot #: a)19E032, b)19E033

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations