PlainRecalls
FDA Drug Moderate Class II Terminated

Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Reported: February 9, 2022 Initiated: January 24, 2022 #D-0478-2022

Product Description

Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Reason for Recall

cGMP deviations

Details

Recalling Firm
Ultra Seal Corporation
Units Affected
673,160 packets
Distribution
Nationwide within the United States
Location
New Paltz, NY

Frequently Asked Questions

What product was recalled?
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917. Recalled by Ultra Seal Corporation. Units affected: 673,160 packets.
Why was this product recalled?
cGMP deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 9, 2022. Severity: Moderate. Recall number: D-0478-2022.