FDAClass IIMarch 2, 2022

Sinus Severe recall: CGMP Deviations

Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10

Why was Sinus Severe 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: 1BK0931, Exp 12/31/2022; 1CK0900, Exp 01/31/2023; 1HK1196, Exp 02/28/2023

Product
Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10
Recalling firm
Perrigo Company PLC
Quantity
79,776 botles
Distribution
Nationwide in the USA
Recall date
March 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls