FDAClass IIMay 3, 2023

Glimepiride Tablets recall: CGMP Deviations

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.

Why was Glimepiride Tablets recalled?

CGMP Deviations

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) Lot #: F105692201, Exp. Date 09/30/2024; F105692203, Exp. Date 02/28/2025 b) Lot #: F105692202, Exp. Date 02/28/2025

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.
Recalling firm
Northwind Pharmaceuticals LLC
Quantity
a) 198 bottles; b) 22 bottles
Distribution
Nationwide with the United States
Recall date
May 3, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls