Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

Recall Number: D-1234-2020

Firm: Aurobindo Pharma USA Inc.

Classification: Class II

Status: Terminated

Report Date: 20200422

Initiation Date: 20200318

Termination Date: 20240325

Reason for Recall

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

Product Description

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90