FDA-Drug2022-02-09Class II

Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation
Hazard

cGMP deviations

Sold states
Nationwide within the United States
Affected count
673,160 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2022

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