FDAFDA · Food and drugs·Recall number D-0773-2023
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Published June 7, 2023 · Recall initiated: May 3, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denison Pharmaceuticals, LLC
- Distributor
- Product was distributed Nationwide.
- Lot
- Lot 8290V, Exp: 10-2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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