FDA Drug · D-0557-2023

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

Class II · Terminated

CGMP deviations.

Affected lots / codes — check yours against thisLots: L22C80, I22D93, K21C72 Exp. 11/30/23; A23A90, B23A09 Exp. 07/31/24; K22C33 Exp. 05/31/24; G22E88, G22F66, I22E27, C22B27, D22B94, E22C71 Exp. 02/28/24; I21E36 Exp. 09/30/23

Recalling firm: PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 352 bottles
Distribution: Nationwide in the US.
Recall initiated: April 6, 2023
Classified: May 1, 2023
Terminated: April 30, 2024
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0557-2023%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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