4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00

Recall Number: D-0524-2022

Firm: ULTRAtab Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220216

Initiation Date: 20220126

Termination Date: 20250107

CGMP Deviations

4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00