Recalls / Class II
Class IID-1195-2018
Product
Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7
- Affected lot / code info
- Lot: 090915A, Exp 09/2018
Why it was recalled
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Recalling firm
- Firm
- Beaumont Bio-med, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 21 1st Ave NE, N/A, Waukon, Iowa 52172-1705
Distribution
- Quantity
- 160 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-31
- FDA classified
- 2018-09-17
- Posted by FDA
- 2018-09-26
- Terminated
- 2022-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1195-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.