Recalls / Class II
Class IID-0773-2023
Product
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
- Affected lot / code info
- Lot 8290V, Exp: 10-2023
Why it was recalled
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Recalling firm
- Firm
- Denison Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Powder Hill Rd, N/A, Lincoln, Rhode Island 02865-4407
Distribution
- Quantity
- 54,222 bottles
- Distribution pattern
- Product was distributed Nationwide.
Timeline
- Recall initiated
- 2023-05-03
- FDA classified
- 2023-05-31
- Posted by FDA
- 2023-06-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0773-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.