Drug Enforcement D-0168-2025

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

January 8, 2025

Termination Date

—

Product Information

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.
Product quantity
1016 50-count cartons
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0168-2025
Event ID
95919
Recall initiation date
December 4, 2024
Center classification date
December 31, 2024
Code info
Lot # 47101; Exp. 02/2026
More code info
—