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Class II Recall
Denison Pharmaceuticals, LLC
Product
Safe 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.
Reason
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Classification
Class II
Status
Ongoing
Lot
Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023
Date
2023-06-07
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.