Drug Enforcement D-0559-2023

CGMP deviations.

Status

Terminated

Classification

Class II

Report Date

May 10, 2023

Termination Date

April 30, 2024

Product Information

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
Product quantity
186 bottles
Reason for recall
CGMP deviations.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US.

Location & Firm

Recalling firm
PD-Rx Pharmaceuticals, Inc.
Address
727 N Ann Arbor Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0559-2023
Event ID
92081
Recall initiation date
April 6, 2023
Center classification date
May 1, 2023
Code info
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
More code info
—