Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per ...
FDA Recall #D-0606-2022 — Class II — October 26, 2021
Product Description
Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-511-10
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
21,4824 bottles
Distribution
Nationwide in the USA
Code Information
Batch: 1BK0716, Exp 12/31/2022); 1CK0899, Exp 01/31/2023; 1FK1163, Exp 01/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated