Mylan Pharmaceuticals Inc.

• Prazosin hydrochloride3 products
• ArmodafinilNuvigil · 3 products
• Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 3 products
• Telmisartan3 products
• EszopicloneLunesta · 3 products
• SumatriptanImitrex, Tosymra, Zembrace Symtouch · 3 products
• Verapamil hydrochloride3 products
• Medroxyprogesterone acetateProvera, Depo-Provera, Depo-Subq Provera · 3 products
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 3 products
• Prednisone3 products
• AtenololTenormin · 3 products
• PhenytoinDilantin, Phenytek, Phenytoin Infatabs · 3 products
• Fluticasone propionate and salmeterolFluticasone Propionate and Salmeterol Diskus, Advair Diskus, Advair HFA · 3 products
• AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
• Metoprolol tartrate and hydrochlorothiazide3 products
• Midodrine hydrochloride3 products
• TacrolimusPrograf, Envarsus XR, Astagraf XL · 3 products
• PitavastatinZypitamag, Livalo · 3 products
• LevetiracetamKeppra, Spritam, Keppra XR · 3 products
• DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 3 products
• Risedronate sodium (risedronate sodium hemipentahydrate / risedronate sodium monohydrate)Actonel, Atelvia · 3 products
• ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 3 products
• Liothyronine sodiumCytomel, Liomny · 3 products
• Bisoprolol fumarate and hydrochlorothiazide3 products
• Metolazone3 products
• RivastigmineRivastigmine Transdermal System, Exelon · 3 products
• MirtazapineRemeronsoltab, Remeron · 3 products
• CitalopramCelexa · 3 products
• SildenafilViagra, Vybrique, Revatio · 3 products
• VoriconazoleVfend · 3 products
• Saxagliptin and metformin hydrochloride3 products
• Disopyramide phosphateNorpace · 2 products
• AllopurinolAloprim · 2 products
• TeriflunomideAubagio · 2 products
• AmbrisentanLetairis · 2 products
• Abiraterone acetateZytiga, Abirtega, Yonsa · 2 products
• Glatiramer acetateGlatopa, Copaxone · 2 products
• FluvastatinLescol XL · 2 products
• Colestipol hydrochlorideColestid · 2 products
• EplerenoneInspra · 2 products
• Chlordiazepoxide and amitriptyline hydrochloride2 products
• Atovaquone and proguanil hydrochlorideMalarone · 2 products
• Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 products
• Saxagliptin2 products
• Almotriptan2 products
• Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 2 products
• Budesonide and formoterol fumarate dihydrateSymbicort, Breyna · 2 products
• Diclofenac sodium and misoprostolArthrotec, Dicloenac Sodium and Misoprostol DR · 2 products
• MisoprostolCytotec · 2 products
• Tamoxifen citrateSoltamox · 2 products
• EsomeprazoleNexium · 2 products
• Carbidopa and levodopaCrexont, Rytary, Sinemet · 2 products
• DexlansoprazoleDexilant · 2 products
• Imatinib mesylateGleevec, Imkeldi · 2 products
• PrasugrelEffient · 2 products
• Acitretin2 products
• Dabigatran etexilatePradaxa · 2 products
• Nevirapine2 products
• Cysteamine bitartrateProcysbi, Cystagon · 2 products
• ValacyclovirValtrex · 2 products
• Miconazole nitrate, zinc oxide, white petrolatumVusion · 2 products
• SulfasalazineAzulfidine, Azulfidine En-Tabs · 2 products
• FluconazoleDiflucan · 2 products
• TicagrelorBrilinta · 2 products
• ChlorthalidoneThalitone, Hemiclor · 2 products
• PenciclovirDenavir · 2 products
• Norethindrone acetate and ethinyl estradiolJunel 21 Day, Loestrin 21 Day, Fyavolv · 2 products
• Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 2 products
• Meclofenamate sodium2 products
• Eletriptan hydrobromideRelpax · 2 products
• Triazolam2 products
• GabapentinNeurontin, Gralise, Relgaabi · 1 product
• Candesartan cilexetil and hydrochlorothiazideAtacand Hct · 1 product
• Norelgestromin and ethinyl estradiolZafemy, Xulane, Gwyn Lo · 1 product
• DapsoneAczone · 1 product
• Acamprosate calcium1 product
• Bromocriptine mesylateCycloset · 1 product
• Silver sulfadiazineSsd Cream, Silvadene, Thermazene Silver Sulfadiazine · 1 product
• SucralfateCarafate · 1 product
• Formoterol fumaratePerforomist · 1 product
• Ferric citrate (tetraferric tricitrate decahydrate)Auryxia · 1 product
• ExemestaneAromasin · 1 product
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 1 product
• ScopolamineScopolamine Trandermal System, Transderm Scop · 1 product
• Ipratropium bromideAtrovent HFA · 1 product
• TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 1 product
• BexaroteneTargretin · 1 product
• DifluprednateDifluprednate Ophthalmic Emulsion, Durezol · 1 product
• Phenelzine sulfateNardil · 1 product
• LinezolidZyvox · 1 product
• Rifabutin1 product
• MethotrexateRasuvo, Otrexup, Trexall · 1 product
• ColchicineColcrys, Gloperba, Lodoco · 1 product
• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
• Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarateComplera · 1 product
• MacitentanOpsumit · 1 product
• FluorouracilFavlyxa, Tolak, Efudex · 1 product
• NorethindroneErrin, Nora Be, Camila · 1 product
• Travoprost ophthalmic solutionTravatan Z, Idose Tr, Travoprost Ophthalmic Soluton · 1 product
• MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
• HalcinonideHalog · 1 product
• Cabergoline1 product
• PregabalinLyrica, Lyrica CR · 1 product
• Spironolactone and hydrochlorothiazide1 product
• SorafenibNexavar · 1 product
• EtoposideVepesid, Avopef, Etopophos · 1 product
• Sertraline hydrochlorideZoloft · 1 product
• LatanoprostIyuzeh, Xalatan, Xelpros · 1 product
• EthosuximideZarontin · 1 product
• Loperamide hydrochloride1 product
• BepotastineBepreve · 1 product
• KetoprofenOrudis · 1 product
• CyclosporineSandimmune, Neoral, Cyclosporine Modified · 1 product
• CarisoprodolSoma · 1 product
• Diphenoxylate hydrochloride and atropine sulfateLomotil · 1 product
• Azelastine hydrochloride and fluticasone propionateDymista · 1 product
• Fosamprenavir calcium1 product
• AbacavirZiagen · 1 product
• Ipratropium bromide and albuterol sulfateCombivent Respimat · 1 product

2022

1. January 26, 2022 · Class II · Terminated · D-0173-2024 · Citalopram

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01

2. January 26, 2022 · Class II · Terminated · D-0202-2024 · Fluticasone propionate and salmeterol

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32

2021

1. September 13, 2021 · Class III · Terminated · D-0798-2021 · Candesartan cilexetil

   Failed Impurities/Degradation Specifications; out of specification for Related Compound

   Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

2. March 15, 2021 · Class II · Terminated · D-0527-2021 · Estradiol

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

2020

1. October 2, 2020 · Class III · Terminated · D-0049-2021 · Candesartan cilexetil and hydrochlorothiazide

   Out-of-specification organic impurity results obtained during routine stability testing.

   Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals I

2. March 23, 2020 · Class III · Terminated · D-1057-2020 · Tacrolimus

   Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.

   Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01

2019

1. October 18, 2019 · Class II · Terminated · D-0155-2020 · Prasugrel

   Failed Dissolution Specification: Low out of specification dissolution results.

   Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

2018

1. December 4, 2018 · Class II · Ongoing · D-0326-2019 · Valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.

2. December 4, 2018 · Class II · Ongoing · D-0328-2019 · Valsartan and hydrochlorothiazide

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morganto

3. December 4, 2018 · Class II · Ongoing · D-0332-2019 · Valsartan and hydrochlorothiazide

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantow

4. December 4, 2018 · Class II · Ongoing · D-0327-2019 · Valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.

5. December 4, 2018 · Class II · Ongoing · D-0330-2019 · Valsartan and hydrochlorothiazide

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantow

6. December 4, 2018 · Class II · Ongoing · D-0324-2019 · Valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.

7. December 4, 2018 · Class II · Ongoing · D-0321-2019 · Amlodipine and valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.

8. December 4, 2018 · Class II · Ongoing · D-0322-2019 · Amlodipine and valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.

9. December 4, 2018 · Class II · Ongoing · D-0329-2019 · Valsartan and hydrochlorothiazide

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgant

10. December 4, 2018 · Class II · Ongoing · D-0331-2019 · Valsartan and hydrochlorothiazide

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgant

11. December 4, 2018 · Class II · Ongoing · D-0325-2019 · Valsartan

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.

12. December 4, 2018 · Class II · Ongoing · D-0320-2019 · Amlodipine and valsartan

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.

13. December 4, 2018 · Class II · Ongoing · D-0323-2019 · Amlodipine and valsartan

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.

14. November 20, 2018 · Class II · Ongoing · D-0314-2019 · Valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.

15. November 20, 2018 · Class II · Ongoing · D-0316-2019 · Valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.

16. November 20, 2018 · Class II · Ongoing · D-0315-2019 · Valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.

17. November 20, 2018 · Class II · Ongoing · D-0313-2019 · Valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.

18. November 20, 2018 · Class II · Ongoing · D-0312-2019 · Amlodipine and valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.

19. November 20, 2018 · Class II · Ongoing · D-0317-2019 · Valsartan and hydrochlorothiazide

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.

20. November 20, 2018 · Class II · Ongoing · D-0318-2019 · Amlodipine and valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.

21. November 20, 2018 · Class II · Ongoing · D-0311-2019 · Amlodipine and valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.

2017

1. October 20, 2017 · Class I · Terminated · D-0150-2018 · Diphenoxylate hydrochloride and atropine sulfate

   SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

   diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977

2. March 20, 2017 · Class II · Terminated · D-0619-2017 · Atorvastatin

   Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

   Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

3. March 20, 2017 · Class II · Terminated · D-0618-2017 · Atorvastatin

   Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

   Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only,

4. March 20, 2017 · Class II · Terminated · D-0620-2017 · Atorvastatin

   Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

   Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

5. March 20, 2017 · Class II · Terminated · D-0621-2017 · Atorvastatin

   Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

   Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

6. January 30, 2017 · Class III · Terminated · D-0861-2017 · Norethindrone acetate and ethinyl estradiol

   Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

   Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx

7. January 19, 2017 · Class II · Terminated · D-0492-2017 · Mirtazapine

   Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

   Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

2014

1. December 17, 2014 · Class II · Terminated · D-0326-2015 · Alprazolam

   Subpotent Drug

   Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4.

2. January 29, 2014 · Class II · Terminated · D-1356-2014 · Fluconazole

   Defective Container: Tamper evident ring failures discovered on some bottles.

   GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1

2013

1. January 30, 2013 · Class II · Terminated · D-147-2013 · Lansoprazole

   Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.

   Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.

2012

1. July 27, 2012 · Class II · Terminated · D-1702-2012 · Levetiracetam

   Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.

   Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05

2. June 29, 2012 · Class II · Terminated · D-066-2013 · Tacrolimus

   Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

   Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

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).