Why it was recalled
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 090915A, Exp 09/2018
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1195-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 31, 2018
- FDA report date
- Sep 26, 2018
- Quantity
- 160 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Beaumont Bio-med, Inc.
Original FDA data
Every field from FDA enforcement report D-1195-2018, exactly as published.
Show all FDA fields
- City
- Waukon
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 80963
- Address
- 21 1st Ave NE
- Code information
- Lot: 090915A, Exp 09/2018
- Postal code
- 52172-1705
- Report date
- Sep 26, 2018
- Product type
- Drugs
- Recall number
- D-1195-2018
- Classification
- Class II
- Recalling firm
- Beaumont Bio-med, Inc.
- Product quantity
- 160 bottles
- Termination date
- Sep 16, 2022
- Reason for recall
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 31, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2018