FDA Drug recall D-0773-2023
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle
- FDA Drug
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle by Denison Pharmaceuticals, citing CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0773-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-03 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denison Pharmaceuticals |
| Distribution | US |
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.
Identifiers
| code_info | Lot 8290V, Exp: 10-2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0773-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.