D-0168-2025 Class II Ongoing
FDA drug recall D-0168-2025 was initiated by AvKARE on December 4, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 1016 50-count cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2025
- Initiation Date
- December 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1016 50-count cartons
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide USA
Code Information
Lot # 47101; Exp. 02/2026