FDA recall D-0551-2023

Northwind Pharmaceuticals LLC · Class II · drug

Product

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.

Reason for recall

CGMP Deviations

Distribution

Nationwide with the United States

Key facts

Status
Ongoing
Initiation date
2023-03-16
Report date
2023-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0551-2023