Class II Recall

Denison Pharmaceuticals, LLC

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.
Reason
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Classification
Class II
Status
Ongoing
Lot
Lot 8290V, Exp: 10-2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.