FDA Drug Class II — Moderate

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.

Hazard

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

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Products

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.
Brand
Denison Pharmaceuticals, LLC
UPC
Lot 8639, Exp: 8/2023

Units Affected

13,968 bottles

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