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.

Recall Number: D-0775-2023

Firm: Denison Pharmaceuticals, LLC

Classification: Class II

Status: Ongoing

Report Date: 20230607

Initiation Date: 20230503

Termination Date:

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

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.