FDA recall D-0612-2022

Product

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10

Reason for recall

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-10-26

Report date

2022-03-02

Termination date

2023-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0612-2022