Mylan Institutional LLC

• VancomycinTyzavan, Vancocin · 9 products
• Fondaparinux sodiumArixtra · 8 products
• DocetaxelBeizray, Docivyx · 7 products
• DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 7 products
• Remifentanil hydrochlorideUltiva · 6 products
• Eptifibatide6 products
• Adenosine5 products
• LevetiracetamKeppra, Spritam, Keppra XR · 4 products
• Octreotide acetateSandostatin, Bynfezia Pen · 3 products
• Calcitonin salmonMiacalcin · 3 products
• Ferric carboxymaltoseInjectafer · 3 products
• Esmolol hydrochlorideBrevibloc, Esmolol Hydrochloride in Water · 3 products
• Leucovorin calciumVykoura · 3 products
• Triamcinolone acetonideKenalog-40, Triderm, Triesence · 3 products
• Zoledronic acidReclast · 3 products
• Naloxone hydrochlorideNarcan, Rextovy, Zimhi · 3 products
• Isosulfan blue3 products
• DexmedetomidinePrecedex, Dexmedetomidine in Dextrose, Igalmi · 3 products
• GemcitabineAvgemsi, Inlexzo · 3 products
• GranisetronGranisol, Sancuso, Sustol · 3 products
• FamotidinePepcid · 3 products
• Iron sucroseVenofer · 3 products
• Tetradecyl hydrogen sulfate (ester)Sotradecol · 2 products
• DaptomycinDapzura Rt · 2 products
• Amiodarone hydrochloridePacerone, Nexterone · 2 products
• Sodium nitroprussideNipride Rtu · 2 products
• EtomidateAmidate · 2 products
• TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 2 products
• EpoprostenolVeletri · 2 products
• SugammadexBridion · 2 products
• Oxaliplatin2 products
• Pamidronate disodium2 products
• Haloperidol decanoate2 products
• Vecuronium bromide2 products
• Acetazolamide2 products
• Ropivacaine hydrochlorideNaropin · 2 products
• Dimethyl sulfoxideRimso-50 · 1 product
• Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 1 product
• FosaprepitantFocinvez, Emend, Navitrux · 1 product
• Cidofovir dihydrate1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.
• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2026

1. August 26, 2026 · Class II · Ongoing · D-0830-2026 · Mycophenolate mofetil

   Failed Dissolution Specifications

   Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: My

2. July 2, 2026 · Class II · Ongoing · D-0734-2026 · Mycophenolate mofetil

   Presence of precipitate

   Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & ND

2025

1. October 10, 2025 · Class II · Ongoing · D-0214-2026 · Haloperidol

   Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

   Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LL

2022

1. October 7, 2022 · Class I · Terminated · D-0058-2023 · Octreotide acetate

   Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

   Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, ND

2. April 13, 2022 · Class II · Terminated · D-1091-2022 · Clonidine

   cGMP deviations: Temperature abuse

   Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10

3. April 7, 2022 · Class II · Terminated · D-0774-2022 · Rifampin

   Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.

   Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60

2021

1. May 3, 2021 · Class III · Terminated · D-0601-2021 · Thiamine hydrochloride

   Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

   Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institu

2020

1. August 17, 2020 · Class I · Terminated · D-1575-2020 · Amiodarone hydrochloride

   Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

   Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway,

2. August 17, 2020 · Class I · Terminated · D-1576-2020 · Tranexamic acid

   Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

   Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ire

3. July 7, 2020 · Class I · Terminated · D-1484-2020 · Daptomycin

   Presence of Particulate Matter

   Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

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1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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