Recalls / Class II
Class IID-0506-2020
Product
R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
- Affected lot / code info
- Lot #: 28557
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
- a) 1 bottle; b) 11 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-0506-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.