Oklahoma City, OK, United States
PD-Rx Pharmaceuticals, Inc. recalls
12 recalls recorded since 2018, most recently on 4 December 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)0
Terminated or completed12
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 4 December 2024
- Terminated
- 21 March 2025
- Reason
- CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
- Distribution
- Distributed within US: FL, MS, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0163-2025
- DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Terminated Class II Drugs
- Recall started
- 6 April 2023
- Terminated
- 30 April 2024
- Reason
- CGMP deviations.
- Distribution
- Nationwide in the US.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0559-2023, D-0557-2023, D-0558-2023, D-0560-2023, D-0561-2023
- Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
- 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
- Simvastatin USP, 10 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 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-9
- Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008
- 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
Terminated Class II Drugs
- Recall started
- 6 June 2022
- Terminated
- 17 June 2024
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1162-2022, D-1163-2022, D-1161-2022
- Losartan Potassium Tablets, USP 50 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,
- Losartan Potassium Tablets, USP 100 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
- 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,
Terminated Class II Drugs
- Recall started
- 6 October 2020
- Terminated
- 22 October 2021
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Distribution
- AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0060-2021, D-0059-2021
- metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60
- metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Ok
Terminated Class II Drugs
- Recall started
- 17 September 2020
- Terminated
- 5 November 2021
- Reason
- CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
- Distribution
- AZ, OK
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0005-2021
- Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, O
Terminated Class II Drugs
- Recall started
- 5 June 2020
- Terminated
- 8 November 2021
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1307-2020
- metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets
Terminated Class II Drugs
- Recall started
- 5 June 2020
- Terminated
- 8 November 2021
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1333-2020
- metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx
Terminated Class II Drugs
- Recall started
- 15 May 2020
- Terminated
- 8 November 2021
- Reason
- Failed dissolution specifications
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1276-2020
- Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28),
Terminated Class II Drugs
- Recall started
- 10 January 2020
- Terminated
- 23 March 2021
- Reason
- CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
- Distribution
- AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0826-2020
- ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-cou
Terminated Class II Drugs
- Recall started
- 8 March 2019
- Terminated
- 16 June 2021
- Reason
- CGMP deviation: Product found to contain trace amounts of NMBA
- Distribution
- AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0341-2021
- Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90
Terminated Class II Drugs
- Recall started
- 7 August 2018
- Terminated
- 7 May 2020
- Reason
- Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1127-2018
- Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bot
Terminated Class II Drugs
- Recall started
- 25 January 2018
- Terminated
- 7 May 2020
- Reason
- CGMP deviations.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0341-2018
- PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.