RecallRadar

FDA Drug recall D-0468-2022

CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afa…

On 2022-02-09 the FDA classified a Class II recall of CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afa… by Ultra Seal, citing cGMP deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0468-2022
ClassificationClass II
Statusterminated
Initiated2022-01-24
Published2022-02-09
Last updated2026-09-13 11:52 UTC
CompanyUltra Seal
DistributionUS

Product

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

cGMP deviations

Identifiers

code_infoLot #: AK9492, Exp. Date 02/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0468-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.