FDAClass IIFebruary 9, 2022

Sinus Relief Headache/Nasal recall: CGMP Deviations

Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

Why was Sinus Relief Headache/Nasal recalled?

cGMP deviations

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?

Lot #: AK9436, Exp. Date 01/2022

Product
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Recalling firm
Ultra Seal Corporation
Quantity
227,010 packets
Distribution
Nationwide within the United States
Recall date
February 9, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls