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FDARecalled Jun 7, 2023 · #D-0772-2023

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.

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Classification: Class II Distribution: Product was distributed Nationwide.

Product details

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.
Type
Drugs
Manufacturer
Denison Pharmaceuticals, LLC
Model numbers
8314
UPCs