FDA Drug Recalls

Recalls / Class II

Class IID-0495-2020

Product

Ferrum Phosphoricum 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 64198 9.

Affected lot / code info
Lot # BR18C281

Why it was recalled

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

Recalling firm

Firm
Washington Homeopathic Products, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
260 J R Hawvermale Way, N/A, Berkeley Springs, West Virginia 25411-6957

Distribution

Quantity
462 bottles
Distribution pattern
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia

Timeline

Recall initiated
2019-11-08
FDA classified
2019-11-18
Posted by FDA
2019-11-27
Terminated
2023-01-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0495-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.