FDAFDA · Food and drugs·Recall number D-0519-2023
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.
Published April 12, 2023 · Recall initiated: March 23, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ROSUVASTATIN CALCIUM
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Distributor
- USA Nationwide
- Lot
- a) 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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