FDA-Drug2022-03-02Class II

Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30

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
41,472 bottles
Manufactured in
515 Eastern Ave, Allegan, MI, United States
Products
Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0618-2022

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