Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00

Recall Number: D-0526-2022

Firm: ULTRAtab Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220216

Initiation Date: 20220126

Termination Date: 20250107

Reason for Recall

CGMP Deviations

Product Description

Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00