Home / Recalls / PD-Rx Pharmaceuticals, Inc. / D-0557-2023

D-0557-2023 Class II Terminated

Recalled by PD-Rx Pharmaceuticals, Inc. — Oklahoma City, OK

Recall Details

Product Type
Drugs
Report Date
May 10, 2023
Initiation Date
April 6, 2023
Termination Date
April 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
352 bottles

Product Description

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.

Distribution Pattern

Nationwide in the US.

Code Information

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

Other recalls by PD-Rx Pharmaceuticals, Inc.

  • D-0163-2025 Class II — DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceu (December 4, 2024)
  • D-0558-2023 Class II — Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pk (April 6, 2023)
  • D-0559-2023 Class II — Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: P (April 6, 2023)
  • D-0560-2023 Class II — Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg (April 6, 2023)
  • D-0561-2023 Class II — Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg (April 6, 2023)
  • D-1161-2022 Class II — Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and (June 6, 2022)
  • D-1162-2022 Class II — Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and (June 6, 2022)
  • D-1163-2022 Class II — Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed an (June 6, 2022)
  • D-0060-2021 Class II — metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklah (October 6, 2020)
  • D-0059-2021 Class II — metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 727 (October 6, 2020)