FDAHealthDecember 31, 2025
AvKARE — 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
⚠️ Out of specification for dissolution.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 31, 2025
Nationwide in the USA
What's affected?
- 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
- Brand
- ROSUVASTATIN
- Lot code
- 49124
Additional details
Lot #49124, Exp Date 12/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7,991 5x10 cartons.
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