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Recall Observatory FDA recall evidence

Drug product

Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

D-0894-2021

August 20, 2021

Class II

Product summary

Firm
Washington Homeopathic Products, Inc.
Event
Event 88528
Status
Terminated
Classification
Class II
Quantity
562 bottles
Official record key
drug-enforcement:D-0894-2021

Official wording

Reason: Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Code information: Lot # 26198

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification