Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per...
FDA Recall #D-0612-2022 — Class II — October 26, 2021
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.
Recalling Firm
Perrigo Company PLC — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
19,584 bottles
Distribution
Nationwide in the USA
Code Information
Batch: 1BK0716, Exp 12/31/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated