FDA recall D-0168-2025

AvKARE · Class II · 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.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide USA

Key facts

Status: Ongoing
Initiation date: 2024-12-04
Report date: 2025-01-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0168-2025