Drug product
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
D-0082-2022
Product summary
- Event
- Event 88798
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 30,839 bottles, b) 3,830 bottles
- Official record key
drug-enforcement:D-0082-2022
Official wording
Reason: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Code information: a) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity