Class II
Ongoing
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
- Company
- Denison Pharmaceuticals, Llc
- Recall Initiated
- May 3, 2023
- Posted
- June 7, 2023
- Recall Number
- D-0773-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 54,222 bottles
- Firm Location
- Lincoln, RI, United States
Reason for Recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Distribution
Product was distributed Nationwide.
Lot / Code Info
Lot 8290V, Exp: 10-2023
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