FDA recall D-0552-2023

Product

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.

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-0552-2023