Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00

Recall Number: D-0528-2022

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

Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00