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Recall Observatory FDA recall evidence

Drug product

Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64190 3.

D-0493-2020

November 08, 2019

Class II

Product summary

Firm
Washington Homeopathic Products, Inc.
Event
Event 84213
Status
Terminated
Classification
Class II
Quantity
300 bottles
Official record key
drug-enforcement:D-0493-2020

Official wording

Reason: CGMP Deviations: products were not manufactured under current good manufacturing practices.

Code information: Lot #: BR18B277

Distribution pattern: Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations