FDA Recall Simvastatin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Simvastatin with NDC 68788-9429 was initiated on 03-23-2023 as a Class II recall due to cgmp deviations for the manufacturing firm (accord healthcare) after their inspection. The latest recall number for this product is D-0524-2023 and the recall is currently ongoing .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0524-2023 | 03-23-2023 | 04-12-2023 | Class II | a) 305 Bottles, b) 72 Bottles, c) 617 Bottles | Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703. | Ongoing |
| D-0523-2023 | 03-23-2023 | 04-12-2023 | Class II | 57 Bottles | Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9 | Ongoing |
| D-0522-2023 | 03-23-2023 | 04-12-2023 | Class II | 82 Bottles of 90 Tablets | Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9 | Ongoing |
| D-0525-2023 | 03-23-2023 | 04-12-2023 | Class II | a) 88 Bottles, b) 3 Bottles, c) 175 Bottles | Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703. | Ongoing |
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.