PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: January 8, 2025 Initiated: December 4, 2024 #D-0168-2025

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

Details

Recalling Firm
AvKARE
Units Affected
1016 50-count cartons
Distribution
Nationwide USA
Location
Pulaski, TN

Frequently Asked Questions

What product was recalled?
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.. Recalled by AvKARE. Units affected: 1016 50-count cartons.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on January 8, 2025. Severity: Moderate. Recall number: D-0168-2025.