Denison Pharmaceuticals, LLC recalls Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle
Recalled June 7, 2023 · FDA recall D-0772-2023 · Denison Pharmaceuticals
Hazard
CGMP Deviations: Use of non-food grade lubricant in mixing vessel. · FDA Class II
Units
86,616 4 OZ bottles
Sold at
Product was distributed Nationwide.
Description
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
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.
Manufacturer(s)
Denison Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →