Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00

Recall Number: D-0544-2022

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

Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00