Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count ...
FDA Recall #D-0551-2023 — Class II — March 16, 2023
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.
Reason for Recall
CGMP Deviations
Recalling Firm
Northwind Pharmaceuticals LLC — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 230 bottles; b) 22 bottles
Distribution
Nationwide with the United States
Code Information
a) Lot #: F106252201, Exp. Date 09/30/2024; F106252301, F106252303, Exp. Date 5/31/2025; F106252304, Exp. Date 07/31/2025 b) Lot #: F106252302, Exp. Date 07/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated