Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufac...
FDA Recall #D-0168-2025 — Class II — December 4, 2024
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
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1016 50-count cartons
Distribution
Nationwide USA
Code Information
Lot # 47101; Exp. 02/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated