FDA recall D-0608-2022

Perrigo Company PLC · Class II · drug

Product

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6378-1

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-0608-2022