PlainRecalls
FDA Drug Moderate Class II Terminated

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90

Reported: May 10, 2023 Initiated: April 6, 2023 #D-0559-2023

Product Description

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90

Reason for Recall

CGMP deviations.

Details

Units Affected
186 bottles
Distribution
Nationwide in the US.
Location
Oklahoma City, OK

Frequently Asked Questions

What product was recalled?
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 186 bottles.
Why was this product recalled?
CGMP deviations.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 10, 2023. Severity: Moderate. Recall number: D-0559-2023.