1. Home
  2. Drug Recall Enforcement Reports
  3. Recall Enforcement Event ID: 92268

Recall Enforment Report D-0773-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Denison Pharmaceuticals, LLC, originally initiated on 05-03-2023 for the 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. The product was recalled due to cgmp deviations: use of non-food grade lubricant in mixing vessel.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0773-202305-03-202306-07-2023Class II54,222 bottlesColic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.CGMP Deviations: Use of non-food grade lubricant in mixing vessel.Ongoing
D-0774-202305-03-202306-07-2023Class II4,812 unitsPin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02CGMP Deviations: Use of non-food grade lubricant in mixing vessel.Ongoing
D-0772-202305-03-202306-07-2023Class II86,616 4 OZ bottlesSafe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.CGMP Deviations: Use of non-food grade lubricant in mixing vessel.Ongoing
D-0775-202305-03-202306-07-2023Class II13,968 bottlesSafe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.CGMP Deviations: Use of non-food grade lubricant in mixing vessel.Ongoing