FDA recall D-0943-2023

Product

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807

Reason for recall

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

Distribution

nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-06-23

Report date

2023-08-02

Termination date

2024-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0943-2023