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.

Recall Number: D-0772-2023

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 DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.