Drug product
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05
D-0228-2022
Product summary
- Event
- Event 88866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49
- Official record key
drug-enforcement:D-0228-2022
Official wording
Reason: Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Code information: GS040048, Exp: 1/2023
Distribution pattern: Distributed to two distributors located in AZ and MO
Derived failure modes
-
Unknown
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity