Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count...
FDA Recall #D-0552-2023 — Class II — March 16, 2023
Product Description
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
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) 198 bottles; b) 22 bottles
Distribution
Nationwide with the United States
Code Information
a) Lot #: F105692201, Exp. Date 09/30/2024; F105692203, Exp. Date 02/28/2025 b) Lot #: F105692202, Exp. Date 02/28/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated