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

Recall Number: D-0486-2022

Firm: Ultra Seal Corporation

Classification: Class II

Status: Terminated

Report Date: 20220209

Initiation Date: 20220124

Termination Date: 20231016

cGMP deviations

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