FDA recall D-0465-2022

Product

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

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-0465-2022