Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03

Recall Number: D-0483-2022

Firm: Ultra Seal Corporation

Classification: Class II

Status: Terminated

Report Date: 20220209

Initiation Date: 20220124

Termination Date: 20231016

cGMP deviations

Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03