PlainRecalls
FDA Drug Moderate Class II Terminated

CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2

Reported: February 9, 2022 Initiated: January 24, 2022 #D-0468-2022

Product Description

CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2

Reason for Recall

cGMP deviations

Details

Recalling Firm
Ultra Seal Corporation
Units Affected
225,350 packets
Distribution
Nationwide within the United States
Location
New Paltz, NY

Frequently Asked Questions

What product was recalled?
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2. Recalled by Ultra Seal Corporation. Units affected: 225,350 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-0468-2022.