FDA Recall Ezetimibe And Simvastatin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Ezetimibe And Simvastatin with NDC 51407-190 was initiated on 10-14-2021 as a Class II recall due to failed excipient specification; product manufactured using an excipient found to be oos for conductivity The latest recall number for this product is D-0228-2022 and the recall is currently terminated as of 11-10-2022 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0228-2022 | 10-14-2021 | 11-17-2021 | Class II | 49 | 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 | Terminated |
| D-0227-2022 | 10-14-2021 | 11-17-2021 | Class II | a) 101 b) 145 bottles | Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.