Drug product
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
D-0168-2025
Product summary
- Firm
- AvKARE
- Event
- Event 95919
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1016 50-count cartons
- Official record key
drug-enforcement:D-0168-2025
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 47101; Exp. 02/2026
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications