Drug product
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) 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, , packaged in bottles.
D-0081-2022
Product summary
- Event
- Event 88798
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 776 bottles, b) 84 bottles
- Official record key
drug-enforcement:D-0081-2022
Official wording
Reason: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Code information: a) L100256, exp 01/2023; b) L100257, 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