Teva Pharmaceuticals USA

FDA Drug Class II Terminated

PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fibe

August 6, 2018 Teva Pharmaceuticals USA N/A units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Pa

August 6, 2018 Teva Pharmaceuticals USA 3,397 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Pa

August 6, 2018 Teva Pharmaceuticals USA N/A units

FDA Drug Class II Terminated

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Laude

August 6, 2018 Teva Pharmaceuticals USA 27,816 bottles units

FDA Drug Class II Terminated

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham

August 6, 2018 Teva Pharmaceuticals USA 13,225 bottles units

FDA Drug Class II Terminated

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Laud

August 6, 2018 Teva Pharmaceuticals USA 3,785 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Pa

August 6, 2018 Teva Pharmaceuticals USA 82,291 bottles units

FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, In

July 16, 2018 Teva Pharmaceuticals USA 164,922 bottles units

FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma,

July 16, 2018 Teva Pharmaceuticals USA 64,168 bottles units

FDA Drug Class II Ongoing

Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Phar

July 16, 2018 Teva Pharmaceuticals USA 30,793 90-count bottles, 1,158 1000-count bottles units

FDA Drug Class II Ongoing

Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma

July 16, 2018 Teva Pharmaceuticals USA 8,046 30-count bottles, 20,841 90-count bottles units

FDA Drug Class II Terminated

Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, P

July 16, 2018 Teva Pharmaceuticals USA 13,715 120-count bottles units

FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Pars

July 16, 2018 Teva Pharmaceuticals USA 56,603 bottles units

FDA Drug Class II Ongoing

Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Phar

July 16, 2018 Teva Pharmaceuticals USA 13,555 90-count bottles; 2,892 500-count bottles units

FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc

July 16, 2018 Teva Pharmaceuticals USA 99,554 bottles units

FDA Drug Class II Ongoing

Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pha

July 16, 2018 Teva Pharmaceuticals USA 15,347 90-count bottles, 8,378 1000-count bottles units

FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, I

July 16, 2018 Teva Pharmaceuticals USA 195,234 bottles units

FDA Drug Class II Terminated

Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsi

July 5, 2018 Teva Pharmaceuticals USA 27,803 bottles units

FDA Drug Class III Terminated

Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)

April 30, 2018 Teva Pharmaceuticals USA 30,382 patches units

FDA Drug Class II Terminated

Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuti

March 19, 2018 Teva Pharmaceuticals USA 640,486 vaginal inserts units

FDA Drug Class III Terminated

Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North W

February 5, 2018 Teva Pharmaceuticals USA 1,157,095 bottles units

FDA Drug Class III Terminated

Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma,

January 29, 2018 Teva Pharmaceuticals USA 554, 562 (5 pouches/carton) units

FDA Drug Class III Terminated

Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis

January 29, 2018 Teva Pharmaceuticals USA 1,118,046 (5 pouches/carton) units

FDA Drug Class III Terminated

Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis

January 29, 2018 Teva Pharmaceuticals USA 929,916 (5 pouches/carton) units

FDA Drug Class III Terminated

Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma,

January 29, 2018 Teva Pharmaceuticals USA 576, 760 (5 pouches/carton) units

FDA Drug Class II Terminated

Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.

December 14, 2017 Teva Pharmaceuticals USA 4,969 bottles units

FDA Drug Class III Terminated

Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured F

November 28, 2017 Teva Pharmaceuticals USA 42,384 bottles units

FDA Drug Class II Terminated

Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: D

November 20, 2017 Teva Pharmaceuticals USA 5,374 blister cards/28 tablets units

FDA Drug Class II Terminated

Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC

November 9, 2017 Teva Pharmaceuticals USA 3,870 bottles units

FDA Drug Class II Terminated

Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, In

October 25, 2017 Teva Pharmaceuticals USA 140,993 bottles units

FDA Drug Class III Terminated

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

October 17, 2017 Teva Pharmaceuticals USA 58,292 bottles units

FDA Drug Class II Terminated

Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01

September 5, 2017 Teva Pharmaceuticals USA 3,275 bottles units

FDA Drug Class III Terminated

Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmac

August 2, 2017 Teva Pharmaceuticals USA 2,880 cartons (30 unit dose blister pack per carton) units

FDA Drug Class III Terminated

Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, C

July 25, 2017 Teva Pharmaceuticals USA 401,750 cartons units

FDA Drug Class II Terminated

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60

July 24, 2017 Teva Pharmaceuticals USA 28,188 bottles units

FDA Drug Class III Terminated

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

June 29, 2017 Teva Pharmaceuticals USA 25264 bottles units

FDA Drug Class III Terminated

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56

June 29, 2017 Teva Pharmaceuticals USA 196275 bottles units

FDA Drug Class II Terminated

Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19

April 24, 2017 Teva Pharmaceuticals USA N/A units

FDA Drug Class III Terminated

PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured

March 28, 2017 Teva Pharmaceuticals USA 49,089 bottles units

FDA Drug Class III Terminated

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC.,

February 17, 2017 Teva Pharmaceuticals USA 25,916 cartons units

FDA Drug Class II Terminated

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56

February 7, 2017 Teva Pharmaceuticals USA 7,628 HDPE bottles (228,840 tablets) units

FDA Drug Class II Terminated

Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufact

February 2, 2017 Teva Pharmaceuticals USA 17,473 cartons units

FDA Drug Class II Terminated

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

December 21, 2016 Teva Pharmaceuticals USA 133,601 bottles units

FDA Drug Class III Terminated

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC.,

December 1, 2016 Teva Pharmaceuticals USA 6,800 cartons units

FDA Drug Class III Terminated

Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC

November 1, 2016 Teva Pharmaceuticals USA 201, 234 Canisters units

FDA Drug Class III Terminated

Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC

November 1, 2016 Teva Pharmaceuticals USA N/A units

FDA Drug Class III Terminated

PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA

September 22, 2016 Teva Pharmaceuticals USA 5,556 bottles units

FDA Drug Class III Terminated

PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA

September 22, 2016 Teva Pharmaceuticals USA 5,398 bottles units

FDA Drug Class III Terminated

PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA

September 22, 2016 Teva Pharmaceuticals USA 32,015 bottles units

FDA Drug Class III Terminated

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

September 13, 2016 Teva Pharmaceuticals USA 11,214 vials units