Ultra Seal Corporation recalls CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephr
Recalled February 9, 2022 · FDA recall D-0510-2022 · Ultra Seal
Hazard
cGMP deviations · FDA Class II
Units
225,000 packets
Sold at
Nationwide within the United States
Description
cGMP deviations
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
Manufacturer(s)
Ultra Seal Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →