Why it was recalled
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Product description
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Lot numbers, UPCs & expiration codes
Lot 8290V, Exp: 10-2023
Where it was sold
Product was distributed Nationwide.
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-0773-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 3, 2023
- FDA report date
- Jun 7, 2023
- Quantity
- 54,222 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denison Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0773-2023, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- RI
- Status
- Ongoing
- Country
- United States
- Event ID
- 92268
- Address
- 1 Powder Hill Rd
- Code information
- Lot 8290V, Exp: 10-2023
- Postal code
- 02865-4407
- Report date
- Jun 7, 2023
- Product type
- Drugs
- Recall number
- D-0773-2023
- Classification
- Class II
- Recalling firm
- Denison Pharmaceuticals, LLC
- Product quantity
- 54,222 bottles
- Reason for recall
- CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
- Distribution pattern
- Product was distributed Nationwide.
- Recall initiation date
- May 3, 2023
- Initial firm notification
- Letter
- Center classification date
- May 31, 2023