AvKARE: Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 502
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- Out of specification for dissolution.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2025-12-31
- Code info
- Lot #49124, Exp Date 12/31/2026
- Product quantity
- 7,991 5x10 cartons
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Pulaski
- State
- TN
- Country
- United States
- Event id
- 98246
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