Class II · ModerateActive recall
Rosuvastatin Calcium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) Lot: F2022N, Exp. Date: 2/29/2024; b) Lot: F0322I, Exp. Date: 8/31/2023; Lot: J1322H, Exp. Date: 2/29/2024; Lot: K0222N, Exp. Date: 6/30/2024; Lot: L2322D and Lot: L2822J, Exp. Date:7/31/2025.
Where it was soldUSA Nationwide
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 for the manufacturing Firm (Accord Healthcare) after their 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 byPreferred Pharmaceuticals Inc.
| Brand name | ROSUVASTATIN CALCIUM |
| Generic name | ROSUVASTATIN CALCIUM |
| Active ingredient(s) | ROSUVASTATIN CALCIUM |
| Distributed by / for | Preferred Pharmaceuticals, Inc. |
| NDC | 68788-7086-3 |
Show the full FDA record
| Full product label | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. |
| Recalling firm | Preferred Pharmaceuticals, Inc. |
| Distribution | USA Nationwide |
| Quantity | a) 59 Bottles, b) 77 Bottles |
| Recall initiated | 2023-03-23 |
| Report date | 2023-04-12 |
| Recall completed | — |
| Recall number | D-0519-2023 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Anaheim CA 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.