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Recall Observatory FDA recall evidence

Drug product

Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

D-1136-2022

May 13, 2022

Class II

Product summary

Firm
Washington Homeopathic Products, Inc.
Event
Event 90202
Status
Terminated
Classification
Class II
Quantity
6,782 glass amber bottles
Official record key
drug-enforcement:D-1136-2022

Official wording

Reason: cGMP deviations

Code information: Lot# 17931-1, 26684, 17528-1, 30755, 30406, 30515, 29079, 29221, 26953, 23757

Distribution pattern: Product was distributed USA nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations