Drug recall D-0557-2023

Class II Terminated reported May 10, 2023

Product

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

Reason for recall

CGMP deviations.

Lots and codes

Lots: 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

Recall details

Recalling firm
PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
Quantity
352 bottles
Distribution
Nationwide in the US.
Type
Voluntary: Firm initiated
Recall initiated
April 6, 2023
Terminated
April 30, 2024