FDA-Drug2022-02-09Class II
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
Ultra Seal Corporation
Hazard
cGMP deviations
Sold states
Nationwide within the United States
Affected count
225,000 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2022Don't want to check this manually?
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