Ascend Laboratories, LLC

• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
• Telmisartan3 products
• Cefdinir3 products
• DroxidopaNorthera · 3 products
• Lanthanum carbonateFosrenol · 3 products
• Mycophenolate mofetilCellcept, Myhibbin · 3 products
• TacrolimusPrograf, Envarsus XR, Astagraf XL · 3 products
• Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 3 products
• DronabinolMarinol, Syndros · 3 products
• CarbamazepineTegretol XR, Equetro, Carbatrol · 3 products
• DuloxetineDrizalma Sprinkle · 3 products
• Triamcinolone acetonideKenalog-40, Triderm, Triesence · 3 products
• Olmesartan medoxomilBenicar · 3 products
• Dabigatran etexilatePradaxa · 3 products
• SirolimusHyftor, Fyarro · 3 products
• CinacalcetSensipar · 3 products
• NifedipineProcardia XL · 3 products
• Cefuroxime axetil2 products
• FinasteridePropecia, Proscar · 2 products
• RoflumilastZoryve, Daliresp · 2 products
• Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 2 products
• CholestyramineQuestran, Prevalite, Cholestyramine Light · 2 products
• RanolazineAspruzyo Sprinkle · 2 products
• ChlorthalidoneThalitone, Hemiclor · 2 products
• ErythromycinEry, Ery-Tab · 2 products
• RasagilineAzilect · 2 products
• CapecitabineXeloda · 2 products
• Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 2 products
• Varenicline tartrateChantix, Tyrvaya · 2 products
• Fesoterodine fumarateToviaz · 2 products
• TicagrelorBrilinta · 2 products
• Solifenacin succinate2 products
• Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 2 products
• Imatinib mesylateGleevec, Imkeldi · 2 products
• DapagliflozinFarxiga · 2 products
• Cefprozil2 products
• Colesevelam hydrochloride2 products
• LansoprazolePrevacid Solutab, Prevacid · 2 products
• Dimethyl fumarateTecfidera · 2 products
• Benzonatate2 products
• Morphine sulfateMs Contin, Mitigo, Duramorph · 2 products
• FebuxostatUloric · 2 products
• RiluzoleTiglutik · 1 product
• FingolimodGilenya · 1 product
• DiclofenacZipsor, Lofena, Cambia · 1 product
• RivaroxabanXarelto · 1 product
• Ondansetron1 product
• ClopidogrelPlavix · 1 product
• Rabeprazole sodiumAciphex · 1 product
• ItraconazoleTolsura, Sporanox · 1 product
• Enalapril maleateVasotec, Epaned · 1 product
• FosfomycinContepo · 1 product
• Tamsulosin hydrochloride1 product
• Cefixime1 product
• Ibuprofen and famotidine1 product
• SildenafilViagra, Vybrique, Revatio · 1 product
• MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
• Sodium sulfate, potassium sulfate, magnesium sulfateSuprep Bowel Prep, Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep Kit · 1 product
• LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
• BrivaracetamBriviact · 1 product
• Chlordiazepoxide hydrochloride and clidinium bromideLibrax · 1 product
• ColchicineColcrys, Gloperba, Lodoco · 1 product
• MirabegronMyrbetriq, Mirabgeorn · 1 product
• OxcarbazepineTrileptal, Oxtellar XR · 1 product
• RufinamideBanzel · 1 product
• TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
• Silver sulfadiazineSsd Cream, Silvadene, Thermazene Silver Sulfadiazine · 1 product
• DalfampridineAmpyra · 1 product
• EzetimibeZetia · 1 product
• Azelastine hydrochloride1 product
• Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide1 product
• LinezolidZyvox · 1 product
• VigabatrinSabril, Vigadrone, Vigafyde · 1 product

2025

1. July 9, 2025 · Class II · Ongoing · D-0534-2025 · Rizatriptan benzoate

   CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

   Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

2. July 9, 2025 · Class II · Ongoing · D-0533-2025 · Rizatriptan benzoate

   CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

   Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

3. May 23, 2025 · Class II · Ongoing · D-0469-2025 · Cephalexin

   Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

   Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68

4. May 23, 2025 · Class II · Ongoing · D-0468-2025 · Cephalexin

   Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

   Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88

2024

1. December 12, 2024 · Class II · Ongoing · D-0129-2025 · Dabigatran etexilate

   CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

   Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

2. December 12, 2024 · Class II · Ongoing · D-0130-2025 · Dabigatran etexilate

   CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

   Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

3. September 3, 2024 · Class II · Ongoing · D-0668-2024 · Mycophenolic acid

   Failed Dissolution Specifications

   Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.

4. January 16, 2024 · Class II · Ongoing · D-0339-2024 · Fosfomycin

   Failed Impurities/Degradation Specification: Out of specification for organic impurities

   Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippan

2023

1. December 29, 2023 · Class II · Ongoing · D-0237-2024 · Ibuprofen and famotidine

   Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

   Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90

2. July 18, 2023 · Class III · Terminated · D-1145-2023 · Fosfomycin

   Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

   Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57

3. July 11, 2023 · Class II · Ongoing · D-0925-2023 · Fingolimod

   Failed Dissolution Specifications

   Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.

4. March 17, 2023 · Class II · Ongoing · D-0539-2023 · Aripiprazole

   Out of specification (OOS) for Spectroscopic Identification test by IR.

   Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05

5. March 14, 2023 · Class II · Ongoing · D-0533-2023 · Dabigatran etexilate

   CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

   Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

6. March 14, 2023 · Class II · Ongoing · D-0534-2023 · Dabigatran etexilate

   CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

   Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

7. January 5, 2023 · Class II · Terminated · D-0169-2023 · Metoprolol

   Failed Dissolution Specification

   Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054,

8. January 5, 2023 · Class II · Terminated · D-0170-2023 · Metoprolol

   Failed Dissolution Specification

   Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054,

9. January 5, 2023 · Class II · Terminated · D-0171-2023 · Metoprolol

   Failed Dissolution Specification

   Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054,

2022

1. December 28, 2022 · Class II · Terminated · D-0159-2023 · Rasagiline

   Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.

   Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

2. January 12, 2022 · Class II · Terminated · D-0393-2022 · Metoprolol

   Failed Dissolution Specifications.

   Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 070

2021

1. December 21, 2021 · Class II · Terminated · D-0359-2022 · Cefixime

   Failed impurities/degradation specifications

   Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

2. November 3, 2021 · Class II · Terminated · D-0229-2022 · Cefixime

   Failed Impurities/Degradation Specifications

   Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50

3. April 29, 2021 · Class III · Terminated · D-0392-2021 · Olmesartan medoxomil

   Presence of Foreign Tablet/Capsule

   Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

4. January 22, 2021 · Class II · Terminated · D-0264-2021 · Cephalexin

   CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

   Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545

5. January 22, 2021 · Class II · Terminated · D-0263-2021 · Cephalexin

   CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

   Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-54

2020

1. December 17, 2020 · Class II · Terminated · D-0179-2021 · Cephalexin

   Failed Impurity/Degradation Specifications

   Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany

2. December 17, 2020 · Class II · Terminated · D-0178-2021 · Cephalexin

   Failed Impurity/Degradation Specifications

   Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany

3. November 24, 2020 · Class II · Terminated · D-0173-2021 · Tizanidine

   Failed Dissolution Specifications; Out of Specification (low) results were obtained.

   Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.

4. November 23, 2020 · Class II · Terminated · D-0185-2021 · Cephalexin

   Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.

   Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai

5. January 24, 2020 · Class II · Terminated · D-0828-2020 · Olmesartan medoxomil

   cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.

   Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.

6. January 22, 2020 · Class III · Terminated · D-0827-2020 · Minocycline hydrochloride

   Failed Dissolution Specifications: low out of specification results for dissolution testing.

   Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

2019

1. July 16, 2019 · Class II · Terminated · D-1509-2019 · Temozolomide

   CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

   Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed

2. July 16, 2019 · Class II · Terminated · D-1512-2019 · Temozolomide

   CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

   Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed

3. July 16, 2019 · Class II · Terminated · D-1510-2019 · Temozolomide

   CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

   Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed

4. July 16, 2019 · Class II · Terminated · D-1511-2019 · Temozolomide

   CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

   Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed

5. July 16, 2019 · Class II · Terminated · D-1513-2019 · Temozolomide

   CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

   Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.

6. July 16, 2019 · Class II · Terminated · D-1508-2019 · Temozolomide

   CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

   Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed b

7. February 22, 2019 · Class II · Terminated · D-1066-2019 · Tamsulosin hydrochloride

   Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.

   Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-

2018

1. November 14, 2018 · Class II · Terminated · D-0287-2019 · Quetiapine

   Presence of Foreign Substance; metal shard found in tablet

   Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code:

2017

1. May 5, 2017 · Class III · Terminated · D-1134-2017 · Amlodipine

   PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.

   AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10

2016

1. November 2, 2016 · Class II · Terminated · D-0163-2017 · Metformin hydrochloride

   Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

   Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10

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).