FDA-Drug2022-02-09Class II

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

Ultra Seal Corporation
Hazard

cGMP deviations

Sold states
Nationwide within the United States
Affected count
313,000 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0465-2022

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief