FDA recall D-0772-2023

Denison Pharmaceuticals, LLC · Class II · drug

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.

Reason for recall

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

Distribution

Product was distributed Nationwide.

Key facts

Status: Ongoing
Initiation date: 2023-05-03
Report date: 2023-06-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lincoln, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0772-2023