Product: Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Reason for recall: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated: 20200318
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated