Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per b...
FDA Recall #D-0618-2022 — Class II — October 26, 2021
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.
Recalling Firm
Perrigo Company PLC — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
41,472 bottles
Distribution
Nationwide in the USA
Code Information
Batch: 1BK0826, Exp 12/31/2022; 1FK1164, Exp 01/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated