FDA Recall Simvastatin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Simvastatin with NDC 65862-052 was initiated on 03-18-2020 as a Class II recall due to cgmp deviations: products were manufactured in a processing area in which water leakage was observed The latest recall number for this product is D-1234-2020 and the recall is currently terminated as of 03-25-2024 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1234-2020 | 03-18-2020 | 04-22-2020 | Class II | 26976 units | Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90 | Terminated |
| D-1842-2019 | 07-29-2019 | 09-04-2019 | Class III | 2,352/1000 count bottles | Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99 | 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.