Safe 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.
Reason
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Classification
Class II
Status
Ongoing
Lot
Lot 8639, Exp: 8/2023
Date
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.
Denison Pharmaceuticals, LLC — Class II Recall | MedicineWatch US