PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 2, 2022 Initiated: October 26, 2021 #D-0612-2022

Product Description

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.

Details

Recalling Firm
Perrigo Company PLC
Units Affected
19,584 bottles
Distribution
Nationwide in the USA
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by Perrigo Company PLC. Units affected: 19,584 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-0612-2022.