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Recall Observatory FDA recall evidence

Drug product

PEPTIME Energy (caffeine 300mg) 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-0502-2022

January 24, 2022

Class II

Product summary

Firm
Ultra Seal Corporation
Event
Event 89464
Status
Terminated
Classification
Class II
Quantity
a)131,112 packets, b) 8,064 bottles
Official record key
drug-enforcement:D-0502-2022

Official wording

Reason: cGMP deviations

Code information: Lot #: a)19E030, b)19E031

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations