FDA-Drug2023-06-07Class II
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Denison Pharmaceuticals, LLC
Hazard
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Sold states
Product was distributed Nationwide.
Affected count
54,222 bottles
Manufactured in
1 Powder Hill Rd, N/A, Lincoln, RI, United States
Products
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0773-2023Don't want to check this manually?
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