Class II · ModerateRecall completed
Rosuvastatin
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatches: a) P2100343, Exp. Date 12/31/2023; P2102371, Exp. Date 3/31/2024; b) P2101966, Exp. Date 2/28/2024; P2104545, Exp. Date 6/30/2024; P2204500, Exp. Date 7/31/2025; P2205415, Exp. Date 8/31/2025; c) P2101591, Exp. Date 2/28/2023; P2200062, Exp. Date 12/31/2024; P2204336, Exp. Date 7/31/2025; P2204337, Exp. Date 7/31/2025; P2205416, Exp. Date 8/31/2025;
Where it was soldUnited States including Puerto Rico and Canada
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: recalling drug products following an FDA inspection.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA foreign manufacturer
| Brand name | ROSUVASTATIN |
| Generic name | ROSUVASTATIN |
| Active ingredient(s) | ROSUVASTATIN CALCIUM |
| Distributed by / for | Accord Healthcare, Inc., Durham, NC 27703 |
| NDC | 16729-287-10 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Accord Healthcare, Inc. |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 102,360 bottles |
| Recall initiated | 2023-02-07 |
| Report date | 2023-03-08 |
| Recall completed | 2024-04-22 |
| Recall number | D-0407-2023 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Durham NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.