FDA Drug Moderate Class II Ongoing

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

Reported: May 3, 2023 Initiated: March 16, 2023 #D-0552-2023

Product Description

Reason for Recall

CGMP Deviations

Details

Recalling Firm: Northwind Pharmaceuticals LLC
Units Affected: a) 198 bottles; b) 22 bottles
Distribution: Nationwide with the United States
Location: Indianapolis, IN

Frequently Asked Questions

What product was recalled? ▼

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.. Recalled by Northwind Pharmaceuticals LLC. Units affected: a) 198 bottles; b) 22 bottles.

Why was this product recalled? ▼

CGMP Deviations

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0552-2023.