Drug 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.
D-0773-2023
Product summary
- Event
- Event 92268
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 54,222 bottles
- Official record key
drug-enforcement:D-0773-2023
Official wording
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Code information: Lot 8290V, Exp: 10-2023
Distribution pattern: Product was distributed Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations