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
Rosuvastatin Tablets Recall Summary AvKARE is recalling Rosuvastatin Tablets USP 10 mg (NDC 50268-709-15) distributed nationwide because the tablets do not dissolve properly in the body as specified. This is a Class I recall, the most serious category. The recall affects patients who received this medication in all U.S. states and Washington, D.C.
- Recalling firm
- AvKARE
- 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
- Reason
- Out of specification for dissolution.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-12-31
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/81cf15b3-f227-4994-9df9-f9001a6e8ebb