D-0773-2023 Class II Ongoing
FDA drug recall D-0773-2023 was initiated by Denison Pharmaceuticals, LLC on May 3, 2023 and is designated Class II. Reason for recall: CGMP Deviations: Use of non-food grade lubricant in mixing vessel. The recall status is ongoing. Affected quantity: 54,222 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2023
- Initiation Date
- May 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,222 bottles
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.
Reason for Recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Distribution Pattern
Product was distributed Nationwide.
Code Information
Lot 8290V, Exp: 10-2023