Macleods Pharmaceuticals Limited

• Venlafaxine hydrochlorideEffexor XR · 3 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 3 products
• Mexiletine hydrochloride3 products
• Losartan potassium and hydrochlorothiazideHyzaar · 3 products
• MontelukastSingulair · 3 products
• Candesartan cilexetil and hydrochlorothiazideAtacand Hct · 3 products
• DuloxetineDrizalma Sprinkle · 3 products
• Tramadol hydrochlorideConzip · 3 products
• Sevelamer carbonateRenvela · 3 products
• LabetalolLabetalol HCL in Dextrose · 3 products
• Levofloxacin3 products
• PioglitazoneActos · 3 products
• Repaglinide3 products
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 3 products
• Sacubitril and valsartanEntresto · 3 products
• Losartan potassiumLosortan Potassium, Cozaar, Arbli · 3 products
• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
• Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 3 products
• Famciclovir3 products
• Telmisartan3 products
• IrbesartanAvapro · 3 products
• EszopicloneLunesta · 3 products
• Oseltamivir phosphateTamiflu · 3 products
• LamivudineEpivir · 2 products
• Pioglitazone and metformin hydrochlorideActoplus Met · 2 products
• Sevelamer hydrochloride2 products
• TicagrelorBrilinta · 2 products
• TofacitinibXeljanz, Xeljanz XR · 2 products
• Irbesartan and hydrochlorothiazideAvalide · 2 products
• NiacinNiacor · 2 products
• Darifenacin2 products
• Methimazole2 products
• Dimethyl fumarateTecfidera · 2 products
• Silodosin2 products
• Nystatin and triamcinolone acetonide2 products
• Varenicline tartrateChantix, Tyrvaya · 2 products
• FebuxostatUloric · 2 products
• Memantine and donepezilMemantine and Donepezil Hydrochlorides Extended-Release, Namzaric · 2 products
• DesvenlafaxinePristiq Extended-Release · 2 products
• NintedanibOfev · 2 products
• Solifenacin succinate2 products
• NystatinNystop, Klayesta, Nyamyc · 2 products
• DapsoneAczone · 2 products
• Lopinavir and ritonavirKaletra · 2 products
• Fenofibric acid (choline fenofibrate)2 products
• CholestyramineQuestran, Prevalite, Cholestyramine Light · 2 products
• ChlorthalidoneThalitone, Hemiclor · 2 products
• RasagilineAzilect · 2 products
• Nevirapine2 products
• Tolterodine tartrateDetrol · 2 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 2 products
• LansoprazolePrevacid Solutab, Prevacid · 2 products
• DapagliflozinFarxiga · 2 products
• EsomeprazoleNexium · 2 products
• Levocetirizine dihydrochlorideXyzal · 1 product
• OxcarbazepineTrileptal, Oxtellar XR · 1 product
• Entacapone1 product
• Sodium sulfate, potassium sulfate, magnesium sulfateSuprep Bowel Prep, Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep Kit · 1 product
• RifapentinePriftin · 1 product
• Efavirenz1 product
• Tenofovir disoproxil fumarateViread · 1 product
• Colesevelam hydrochloride1 product
• Propylthiouracil1 product
• MoxifloxacinVigamox · 1 product
• AcyclovirZovirax, Avaclyr · 1 product
• RivaroxabanXarelto · 1 product
• Cevimeline hydrochlorideEvoxac · 1 product
• Fluocinonide1 product
• Triamterene and hydrochlorothiazide1 product
• ClopidogrelPlavix · 1 product
• EzetimibeZetia · 1 product
• Lamivudine and zidovudineCombivir · 1 product
• Ibandronate sodium1 product
• ColchicineColcrys, Gloperba, Lodoco · 1 product
• PirfenidoneEsbriet · 1 product
• Emtricitabine and tenofovir disoproxil fumarateTruvada · 1 product
• Efavirenz, emtricitabine and tenofovir disoproxil fumarate1 product
• Tamsulosin hydrochloride1 product
• LinezolidZyvox · 1 product
• LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
• Abacavir and lamivudine1 product
• Pyrazinamide1 product
• Trospium chloride1 product

2022

1. April 15, 2022 · Class II · Terminated · D-0833-2022 · Losartan potassium

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

   Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro,

2. April 15, 2022 · Class II · Terminated · D-0835-2022 · Losartan potassium and hydrochlorothiazide

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

   Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods P

3. April 15, 2022 · Class II · Terminated · D-0837-2022 · Losartan potassium and hydrochlorothiazide

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

   Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods

4. April 15, 2022 · Class II · Terminated · D-0836-2022 · Losartan potassium and hydrochlorothiazide

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

   Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Ph

5. March 10, 2022 · Class III · Terminated · D-0762-2022 · Risedronate

   FAILED CONTENT UNIFORMITY SPECIFICATIONS

   Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-0

6. February 16, 2022 · Class II · Terminated · D-0639-2022 · Olanzapine

   cGmp Deviations

   Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-0

7. February 15, 2022 · Class II · Terminated · D-0632-2022 · Amlodipine and olmesartan medoxomil

   cGMP deviations

   Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pra

2021

1. October 18, 2021 · Class III · Terminated · D-0079-2022 · Rizatriptan benzoate

   Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

   Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutic

2. October 18, 2021 · Class III · Terminated · D-0080-2022 · Rizatriptan benzoate

   Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

   Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuti

3. October 18, 2021 · Class III · Terminated · D-0078-2022 · Rizatriptan benzoate

   Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

   Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Ma

4. August 2, 2021 · Class II · Terminated · D-0787-2021 · Clopidogrel

   Presence of foreign matter

   Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-

5. March 22, 2021 · Class III · Terminated · D-0329-2021 · Candesartan cilexetil

   Failed Impurities/Degradation Specifications

   Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-1

6. March 15, 2021 · Class II · Terminated · D-0509-2021 · Amlodipine and olmesartan medoxomil

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal

2020

1. January 24, 2020 · Class III · Terminated · D-0838-2020 · Pioglitazone and metformin hydrochloride

   Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

   Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himacha

2. January 20, 2020 · Class III · Terminated · D-0823-2020 · Montelukast

   Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product

   Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111

2019

1. September 23, 2019 · Class II · Terminated · D-0140-2020 · Pioglitazone

   Superpotent

   Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 333

2. August 21, 2019 · Class III · Terminated · D-1851-2019 · Pramipexole dihydrochloride

   Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

   Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33

3. July 17, 2019 · Class II · Terminated · D-1844-2019 · Tamsulosin hydrochloride

   Failed Dissolution Specifications

   Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ

4. June 20, 2019 · Class II · Terminated · D-1458-2019 · Losartan potassium

   CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

   Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44

5. June 20, 2019 · Class II · Terminated · D-1457-2019 · Losartan potassium

   CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

   Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10

6. June 20, 2019 · Class II · Terminated · D-1460-2019 · Losartan potassium and hydrochlorothiazide

   CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

   Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Prade

7. June 20, 2019 · Class II · Terminated · D-1459-2019 · Losartan potassium and hydrochlorothiazide

   CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

   Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Prades

8. June 20, 2019 · Class II · Terminated · D-1461-2019 · Losartan potassium and hydrochlorothiazide

   CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

   Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Prad

9. January 11, 2019 · Class III · Terminated · D-0492-2019 · Clobetasol propionate

   Defective Container; complaints of leakage.

   Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA

2015

1. December 24, 2015 · Class II · Terminated · D-0653-2016 · Pramipexole dihydrochloride

   Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

   Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).