Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant recalled over manufacturing violations

Recall date

January 24, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ultra Seal Corporation recalls Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per…

Recall number

D-0486-2022

FDA classification

Class II

Brand / firm

Ultra Seal Corporation

Sold / distributed

Nationwide within the United States

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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