FDAClass IIFebruary 9, 2022

Cold Relief Severe Pain/Cough recall: CGMP Deviations

Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets…

Why was Cold Relief Severe Pain/Cough 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
Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets…
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