PD-Rx Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0163-2025Class IIDULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, OklahomaDecember 4, 2024
D-0557-2023Class IIMontelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 IndApril 6, 2023
D-0560-2023Class IISimvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx PharmaceuApril 6, 2023
D-0559-2023Class IIGlimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx PharmaceuticalsApril 6, 2023
D-0558-2023Class IISimvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx PharmaceApril 6, 2023
D-0561-2023Class IISimvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx PharmaceuApril 6, 2023
D-1162-2022Class IILosartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx PJune 6, 2022
D-1163-2022Class IILosartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-RxJune 6, 2022
D-1161-2022Class IILosartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx PJune 6, 2022
D-0060-2021Class IImetformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 aOctober 6, 2020
D-0059-2021Class IImetformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tabOctober 6, 2020
D-0005-2021Class IINature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg,September 17, 2020
D-1307-2020Class IImetFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); cJune 5, 2020
D-1333-2020Class IImetFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tJune 5, 2020
D-1276-2020Class IIDoxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-coMay 15, 2020
D-0826-2020Class IIranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-countJanuary 10, 2020
D-0341-2021Class IILosartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OKMarch 8, 2019
D-1127-2018Class IIDoxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-countAugust 7, 2018
D-0341-2018Class IIPD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 taJanuary 25, 2018
D-1118-2017Class IIIPhentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-7August 11, 2017