Home / Recalls / PD-Rx Pharmaceuticals, Inc. / D-0561-2023

D-0561-2023 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
393 bottles

Product Description

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)

Reason for Recall

CGMP deviations.

Distribution Pattern

Nationwide in the US.

Code Information

Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24

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-0557-2023 Class II — Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited A (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)