FDA Recall Rosuvastatin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Rosuvastatin with NDC 16729-286 was initiated on 02-07-2023 as a Class II recall due to cgmp deviations: recalling drug products following an fda inspection. The latest recall number for this product is D-0404-2023 and the recall is currently terminated as of 04-22-2024 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0404-2023 | 02-07-2023 | 03-08-2023 | Class II | 63,247 bottles | Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. | Terminated |
| D-0406-2023 | 02-07-2023 | 03-08-2023 | Class II | 43,302 bottles | Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA | Terminated |
| D-0405-2023 | 02-07-2023 | 03-08-2023 | Class II | 56,862 bottles | Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA | Terminated |
| D-0407-2023 | 02-07-2023 | 03-08-2023 | Class II | 102,360 bottles | Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 16729-287-17, UPC 3 16729 28717 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA | 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.