Teva Pharmaceuticals USA

FDA Drug Class II Terminated

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-

July 29, 2016 Teva Pharmaceuticals USA 27,547 vials units

FDA Drug Class II Terminated

Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03

July 29, 2016 Teva Pharmaceuticals USA 11,844 vials units

FDA Drug Class I Terminated

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack

March 9, 2016 Teva Pharmaceuticals USA 6,291 units units

FDA Drug Class II Terminated

Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18

February 5, 2016 Teva Pharmaceuticals USA 30,891 Bottles units

FDA Drug Class III Terminated

NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL

November 19, 2015 Teva Pharmaceuticals USA 576 bottles units

FDA Drug Class II Terminated

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, T

November 12, 2015 Teva Pharmaceuticals USA 9,717 bottles units

FDA Drug Class I Terminated

ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), N

July 24, 2015 Teva Pharmaceuticals USA 6001 vials units

FDA Drug Class II Terminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles,

June 24, 2015 Teva Pharmaceuticals USA 19,504 bottles units

FDA Drug Class II Terminated

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr

May 11, 2015 Teva Pharmaceuticals USA 889 bottles units

FDA Drug Class III Terminated

QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. m

May 7, 2015 Teva Pharmaceuticals USA 233,364 Inhalers units

FDA Drug Class I Terminated

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 07

April 28, 2015 Teva Pharmaceuticals USA 6195 vials units

FDA Drug Class II Terminated

Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 189

April 13, 2015 Teva Pharmaceuticals USA

FDA Drug Class II Terminated

Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A.,

April 13, 2015 Teva Pharmaceuticals USA

FDA Drug Class II Terminated

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA

October 8, 2014 Teva Pharmaceuticals USA 19,545 Bottles units

FDA Drug Class III Terminated

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

June 17, 2014 Teva Pharmaceuticals USA 1104 blister packs units

FDA Drug Class III Terminated

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 055

June 17, 2014 Teva Pharmaceuticals USA 5265 blister packs units

FDA Drug Class III Terminated

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-1

June 17, 2014 Teva Pharmaceuticals USA 984 blister packs units

FDA Drug Class III Terminated

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

June 17, 2014 Teva Pharmaceuticals USA 1125 blister packs units

FDA Drug Class II Terminated

Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA,

June 5, 2014 Teva Pharmaceuticals USA 3881bottles units

FDA Drug Class II Terminated

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

May 29, 2014 Teva Pharmaceuticals USA 8,472 Bottles units

FDA Drug Class II Terminated

Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.

May 1, 2014 Teva Pharmaceuticals USA 9,882 bottles units

FDA Drug Class II Terminated

QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd.

April 23, 2014 Teva Pharmaceuticals USA 461,592 canisters units

FDA Drug Class II Terminated

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.

April 7, 2014 Teva Pharmaceuticals USA 17,181 bottles units

FDA Drug Class II Terminated

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.

April 7, 2014 Teva Pharmaceuticals USA 53,452 bottles units

FDA Drug Class II Terminated

triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, M

April 1, 2014 Teva Pharmaceuticals USA 89,215 blister pack units

FDA Drug Class II Terminated

INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi,

March 24, 2014 Teva Pharmaceuticals USA 5812 bottles units

FDA Drug Class II Terminated

INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA

March 24, 2014 Teva Pharmaceuticals USA 7,694 bottles units

FDA Drug Class II Terminated

METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA,

March 24, 2014 Teva Pharmaceuticals USA 22820 bottles units

FDA Drug Class II Terminated

GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA

March 24, 2014 Teva Pharmaceuticals USA 2532 bottles units

FDA Drug Class II Terminated

ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY

March 21, 2014 Teva Pharmaceuticals USA 47890 units

FDA Drug Class II Terminated

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA

March 4, 2014 Teva Pharmaceuticals USA 324,648 Bottles units

FDA Drug Class II Terminated

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA

March 4, 2014 Teva Pharmaceuticals USA 598,033 Bottles units

FDA Drug Class II Terminated

Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA

March 4, 2014 Teva Pharmaceuticals USA 127,585 Bottles units

FDA Drug Class II Terminated

Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 5

February 12, 2014 Teva Pharmaceuticals USA 257904 bottles units

FDA Drug Class II Terminated

Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersvill

February 12, 2014 Teva Pharmaceuticals USA 72,356 bottles units

FDA Drug Class III Terminated

QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.

February 11, 2014 Teva Pharmaceuticals USA 257,832 cylinders units

FDA Drug Class II Terminated

Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceu

January 24, 2014 Teva Pharmaceuticals USA 9796 tablets units

FDA Drug Class II Terminated

Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.

January 24, 2014 Teva Pharmaceuticals USA 35746 capsules units

FDA Drug Class II Terminated

Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.

January 24, 2014 Teva Pharmaceuticals USA 10405 tablets units

FDA Drug Class II Terminated

Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02

January 24, 2014 Teva Pharmaceuticals USA 2494 capsules units

FDA Drug Class II Terminated

Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Labora

December 18, 2013 Teva Pharmaceuticals USA 112,800 tablets units

FDA Drug Class II Terminated

Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Se

December 18, 2013 Teva Pharmaceuticals USA 1,249,700 tablets units

FDA Drug Class III Terminated

Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, No

December 4, 2013 Teva Pharmaceuticals USA 379,463 inhalers units

FDA Drug Class II Terminated

Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98

November 26, 2013 Teva Pharmaceuticals USA 10,512 bottles units

FDA Drug Class II Terminated

Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neurosci

October 24, 2013 Teva Pharmaceuticals USA 6,803 cartons units

FDA Drug Class II Terminated

Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5

October 11, 2013 Teva Pharmaceuticals USA 13520 vials units