Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL...
FDA Recall #D-0616-2022 — Class II — October 26, 2021
Product Description
Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10
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
123,408 bottles
Distribution
Nationwide in the USA
Code Information
Batch: 1BK0826, Exp 12/31/2022); 1FK1232, 1BK0964, Exp 01/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated