FDA recall D-0775-2023

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.

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-0775-2023