FDAClass IIFebruary 9, 2022

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant recall: CGMP Deviations

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid…

Why was Pain & Sinus Reliever Pain Reliever/Nasal Decongestant 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 #: AK9527, Exp. Date 03/2022

Product
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid…
Recalling firm
Ultra Seal Corporation
Quantity
887,000 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