D-0082-2022 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) 30,839 bottles, b) 3,830 bottles
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) 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) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023