Product: 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 for recall: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Recall initiated: 20230503
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated