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PD-Rx Pharmaceuticals Recalls
25 recalls on record · January 6, 2016 to January 1, 2025 · Drugs
Recalls by year
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 1, 2025DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC
Hazard: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklaho
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pha
Hazard: CGMP deviations.
July 6, 2022DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, In
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
July 6, 2022DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
July 6, 2022DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 5, 2021DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets
Hazard: CGMP deviation: Product found to contain trace amounts of NMBA
November 11, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
November 11, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
October 14, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4)
Hazard: CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
July 1, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-00
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
June 24, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 4
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
June 3, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-1
Hazard: Failed dissolution specifications
February 12, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-
Hazard: CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
September 5, 2018DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-
Hazard: Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
February 7, 2018DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-
Hazard: CGMP deviations.
August 30, 2017DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count
Hazard: Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
August 9, 2017DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC
Hazard: Failed Tablet/Capsule Specification: out of specification for tablet weight.
January 27, 2016DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-1
Hazard: Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
January 13, 2016DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged b
Hazard: cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
January 13, 2016DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceut
Hazard: cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
January 6, 2016DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklah
Hazard: cGMP Deviations