FDA-Drug2022-03-02Class II

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

Perrigo Company PLC
Hazard

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

Sold states
Nationwide in the USA
Affected count
19,584 bottles
Manufactured in
515 Eastern Ave, Allegan, MI, United States
Products
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

Official notice

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

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