Drug product
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
D-0292-2026
Product summary
- Firm
- AvKARE
- Event
- Event 98246
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,991 5x10 cartons
- Official record key
drug-enforcement:D-0292-2026
Official wording
Reason: Out of specification for dissolution.
Code information: Lot #49124, Exp Date 12/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification