Mylan Pharmaceuticals Inc.

FDA Drug Class II Ongoing

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

February 25, 2025 Mylan Pharmaceuticals Inc. N/A units

FDA Drug Class I Terminated

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by:

July 5, 2022 Mylan Pharmaceuticals Inc. 253,200 pens (50,650/5 per packs) units

FDA Drug Class I Terminated

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 2

April 12, 2022 Mylan Pharmaceuticals Inc. 89,665 vials units

FDA Drug Class II Terminated

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

April 7, 2022 Mylan Pharmaceuticals Inc. 33,893 vials units

FDA Drug Class II Terminated

Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.

April 1, 2022 Mylan Pharmaceuticals Inc. 20,112 bottles units

FDA Drug Class II Terminated

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120,

January 21, 2022 Mylan Pharmaceuticals Inc. 233,199/10 g aerosol containers units

FDA Drug Class I Terminated

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malays

January 5, 2022 Mylan Pharmaceuticals Inc. 73,175 prefilled pens units

FDA Drug Class III Terminated

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: Myl

October 2, 2020 Mylan Pharmaceuticals Inc. 10,695 bottles units

FDA Drug Class III Terminated

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

March 23, 2020 Mylan Pharmaceuticals Inc. 3,816 botlles units

FDA Drug Class II Terminated

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

March 9, 2020 Mylan Pharmaceuticals Inc. 300 100-count bottles units

FDA Drug Class II Terminated

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

January 7, 2020 Mylan Pharmaceuticals Inc. 31,736 bottles of 60 capsules units

FDA Drug Class II Terminated

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

January 7, 2020 Mylan Pharmaceuticals Inc. 16,944 bottles of 30 capsules units

FDA Drug Class II Terminated

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05

October 23, 2019 Mylan Pharmaceuticals Inc. 5,760 bottles units

FDA Drug Class II Terminated

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

October 18, 2019 Mylan Pharmaceuticals Inc. 4,272 bottles units

FDA Drug Class III Terminated

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35

September 6, 2019 Mylan Pharmaceuticals Inc. 13,157 5 mL bottles units

FDA Drug Class III Terminated

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals In

February 13, 2019 Mylan Pharmaceuticals Inc. 8,159 bottles units

FDA Drug Class II Terminated

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India,

February 1, 2019 Mylan Pharmaceuticals Inc. 10,390 bottles units

FDA Drug Class II Terminated

Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505

January 18, 2019 Mylan Pharmaceuticals Inc. 88,090 bottles units

FDA Food Class II Terminated

DrNatura Flora Protect¿ Probiotics

December 10, 2018 Mylan Pharmaceuticals Inc. 2378 Bottles units

FDA Food Class II Terminated

DrNatura Toxinout Kit Broad Spectrum Detoxification Program

December 10, 2018 Mylan Pharmaceuticals Inc. 800 Kits units

FDA Drug Class II Ongoing

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.

November 20, 2018 Mylan Pharmaceuticals Inc. 12,336 bottles units

FDA Drug Class II Ongoing

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.

November 20, 2018 Mylan Pharmaceuticals Inc. 48,302 bottles units

FDA Drug Class II Ongoing

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.

November 20, 2018 Mylan Pharmaceuticals Inc. 23,478 bottles units

FDA Drug Class II Ongoing

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.

November 20, 2018 Mylan Pharmaceuticals Inc. 25,147 bottles units

FDA Drug Class II Ongoing

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.

November 20, 2018 Mylan Pharmaceuticals Inc. 63,213 bottles units

FDA Drug Class II Ongoing

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.

November 20, 2018 Mylan Pharmaceuticals Inc. 12,840 bottles units

FDA Drug Class II Ongoing

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

November 20, 2018 Mylan Pharmaceuticals Inc. 5,660 bottles units

FDA Drug Class II Ongoing

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.

November 20, 2018 Mylan Pharmaceuticals Inc. 24,709 bottles units

FDA Drug Class III Terminated

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morg

August 27, 2018 Mylan Pharmaceuticals Inc. 5,790 cartons (526,890 tablets) units

FDA Drug Class III Terminated

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

August 7, 2018 Mylan Pharmaceuticals Inc. 11,799 bottles of 100 units

FDA Drug Class III Terminated

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

August 7, 2018 Mylan Pharmaceuticals Inc. 656 500-count bottles units

FDA Drug Class II Terminated

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC

July 25, 2018 Mylan Pharmaceuticals Inc. 20,780 bottles units

FDA Drug Class III Terminated

Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01

July 9, 2018 Mylan Pharmaceuticals Inc. 28,436 bottles units

FDA Drug Class III Terminated

Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01

June 7, 2018 Mylan Pharmaceuticals Inc. 1,620 bottles units

FDA Drug Class II Terminated

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22

April 30, 2018 Mylan Pharmaceuticals Inc. 9,906 48-count bottles units

FDA Drug Class II Terminated

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22

April 30, 2018 Mylan Pharmaceuticals Inc. 7,334 48-count bottles units

FDA Drug Class II Terminated

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22

April 30, 2018 Mylan Pharmaceuticals Inc. 3,844 48-count bottles units

FDA Drug Class II Terminated

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01

April 24, 2018 Mylan Pharmaceuticals Inc. 12,924 bottles units

FDA Drug Class II Terminated

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

April 24, 2018 Mylan Pharmaceuticals Inc. 25,488 bottles units

FDA Drug Class II Terminated

Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01

April 24, 2018 Mylan Pharmaceuticals Inc. 11,650 bottles units

FDA Drug Class II Terminated

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

April 24, 2018 Mylan Pharmaceuticals Inc. 8,679 bottles units

FDA Drug Class III Terminated

bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05

November 3, 2017 Mylan Pharmaceuticals Inc. 1,414/500 count bottles units

FDA Drug Class III Terminated

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

May 9, 2017 Mylan Pharmaceuticals Inc. 11,624 pouches units

FDA Drug Class II Terminated

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 037

March 20, 2017 Mylan Pharmaceuticals Inc. 1,233,107 bottles units

FDA Drug Class II Terminated

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.

March 20, 2017 Mylan Pharmaceuticals Inc. 444,201 bottles units

FDA Drug Class II Terminated

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.

March 20, 2017 Mylan Pharmaceuticals Inc. 299,112 bottles units

FDA Drug Class II Terminated

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.

March 20, 2017 Mylan Pharmaceuticals Inc. 452,269 bottles units

FDA Drug Class III Terminated

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 (ND

January 30, 2017 Mylan Pharmaceuticals Inc. 8,605 cartons units

FDA Drug Class III Terminated

Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch conta

January 30, 2017 Mylan Pharmaceuticals Inc. 43,848 cartons units

FDA Drug Class II Terminated

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

January 19, 2017 Mylan Pharmaceuticals Inc. 37,445 bottles units