Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01

Recall Number: D-1231-2020

Firm: Aurobindo Pharma USA Inc.

Classification: Class II

Status: Terminated

Report Date: 20200422

Initiation Date: 20200318

Termination Date: 20240325

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01