Home / Recalls / PD-Rx Pharmaceuticals, Inc. / D-1161-2022

D-1161-2022 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
July 6, 2022
Initiation Date
June 6, 2022
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1441 bottles

Product Description

Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Distribution Pattern

Nationwide

Code Information

Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22

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-0560-2023 Class II — Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg (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-0558-2023 Class II — Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pk (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-0557-2023 Class II — Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited A (April 6, 2023)
  • 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)