FDAClass IIMarch 2, 2022

Soothing 12 Hour Nasal Decongestant Spray No Drip recall: CGMP Deviations

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

Why was Soothing 12 Hour Nasal Decongestant Spray No Drip recalled?

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch: 1BK0826, Exp 12/31/2022; 1FK1164, Exp 01/31/2023

Product
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
Recalling firm
Perrigo Company PLC
Quantity
41,472 bottles
Distribution
Nationwide in the USA
Recall date
March 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls