AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

Recall Number: D-0466-2022

Firm: Ultra Seal Corporation

Classification: Class II

Status: Terminated

Report Date: 20220209

Initiation Date: 20220124

Termination Date: 20231016

cGMP deviations

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989