D-0083-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 10, 2021
- Initiation Date
- October 5, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 3,444 bottles b) 469 bottles c) 142 bottles
Product Description
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 Pattern
Nationwide in the US
Code Information
a) L100160, exp 01/2023 b) L100249, exp 01/2023 c) L100250, exp 01/2023