Northwind Pharmaceuticals LLC: Drug Recall

Recall #D-0551-2023 · 03/16/2023

Class II: Risk

Recall Details

Recall Number: D-0551-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Northwind Pharmaceuticals LLC
Status: Ongoing
Date Initiated: 03/16/2023
Location: Indianapolis, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 230 bottles; b) 22 bottles

Reason for Recall

CGMP Deviations

Product Description

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

Distribution Pattern

Nationwide with the United States

Other Recalls by Northwind Pharmaceuticals LLC

Class II: Risk 08/20/2025

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II: Risk 03/16/2023

CGMP Deviations
Class II: Risk 03/16/2023

CGMP Deviations
Class II: Risk 03/16/2023

CGMP Deviations
Class II: Risk 03/16/2023

CGMP Deviations

View all recalls by Northwind Pharmaceuticals LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.