Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30

Recall Number: D-0557-2023

Firm: PD-Rx Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230510

Initiation Date: 20230406

Termination Date: 20240430

CGMP deviations.

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30