FDA recall D-0510-2022

Ultra Seal Corporation · Class II · drug

Product

CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Reason for recall

cGMP deviations

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2022-01-24
Report date: 2022-02-09
Termination date: 2023-10-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: New Paltz, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2022