FDA recall D-0083-2022

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

Reason for recall

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Distribution

Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2021-10-05
Report date: 2021-11-10
Termination date: 2023-02-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2022