Denison Pharmaceuticals, LLC recalls Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118
Recalled June 7, 2023 · FDA recall D-0775-2023 · Denison Pharmaceuticals
Hazard
CGMP Deviations: Use of non-food grade lubricant in mixing vessel. · FDA Class II
Units
13,968 bottles
Sold at
Product was distributed Nationwide.
Description
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
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.
Manufacturer(s)
Denison Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →