FDAClass IIMay 10, 2023

Glimepiride USP recall: CGMP Deviations

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC…

Why was Glimepiride USP recalled?

CGMP deviations.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lots: A22B45 Exp. 01/31/24; C22A73, E22E41, C22D28, F22B68, G22A29, H22B97, K22A36 Exp. 03/31/24; K22B99, A23D07, B23B25 Exp. 10/31/24; B23B55 Exp. 06/30/25

Product
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC…
Recalling firm
PD-Rx Pharmaceuticals, Inc.
Quantity
186 bottles
Distribution
Nationwide in the US.
Recall date
May 10, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls