PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 2, 2022 Initiated: October 26, 2021 #D-0618-2022

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Perrigo Company PLC
Units Affected
41,472 bottles
Distribution
Nationwide in the USA
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by Perrigo Company PLC. Units affected: 41,472 bottles.
Why was this product recalled?
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 2, 2022. Severity: Moderate. Recall number: D-0618-2022.