Teva Pharmaceuticals USA

FDA Drug Class II Terminated

Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA

February 10, 2021 Teva Pharmaceuticals USA 33,6697 vials units

FDA Drug Class II Terminated

MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., Nor

February 10, 2021 Teva Pharmaceuticals USA 5,086 vials units

FDA Drug Class II Terminated

MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc.,

February 10, 2021 Teva Pharmaceuticals USA 5,378 vials units

FDA Drug Class II Terminated

Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.

February 10, 2021 Teva Pharmaceuticals USA 4,806 vials units

FDA Drug Class II Terminated

Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.

February 10, 2021 Teva Pharmaceuticals USA 12,629 vials units

FDA Drug Class II Terminated

MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.

February 10, 2021 Teva Pharmaceuticals USA 15,043 vials units

FDA Drug Class II Terminated

MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01.

February 10, 2021 Teva Pharmaceuticals USA N/A units

FDA Drug Class II Terminated

Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA

February 10, 2021 Teva Pharmaceuticals USA 705,745 vials units

FDA Drug Class II Terminated

Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.

February 10, 2021 Teva Pharmaceuticals USA 248,565 vials units

FDA Drug Class II Terminated

MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01.

February 10, 2021 Teva Pharmaceuticals USA 6,710 vials units

FDA Drug Class III Terminated

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laborator

November 11, 2020 Teva Pharmaceuticals USA 12,088 cartons units

FDA Drug Class II Terminated

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Pars

October 28, 2020 Teva Pharmaceuticals USA 133,829 bottles units

FDA Drug Class II Terminated

Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Man

September 4, 2020 Teva Pharmaceuticals USA 32,543 cartons units

FDA Drug Class II Terminated

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva

August 24, 2020 Teva Pharmaceuticals USA 1,467,535 bottles units

FDA Drug Class II Terminated

Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva

August 24, 2020 Teva Pharmaceuticals USA 103,940 bottles units

FDA Drug Class II Terminated

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.

August 24, 2020 Teva Pharmaceuticals USA 38,487 bottles units

FDA Drug Class II Terminated

Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA

July 14, 2020 Teva Pharmaceuticals USA 28,596 cartons units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna

June 2, 2020 Teva Pharmaceuticals USA a) 92,793 bottles and b) 4,824 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Di

June 2, 2020 Teva Pharmaceuticals USA a) 15,329 bottles and b) 137 bottles units

FDA Drug Class II Terminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceutical

May 22, 2020 Teva Pharmaceuticals USA 33,280 bottles units

FDA Drug Class II Terminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceutica

May 22, 2020 Teva Pharmaceuticals USA 41,348 bottles units

FDA Drug Class II Terminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceutica

May 22, 2020 Teva Pharmaceuticals USA 84,209 bottles units

FDA Drug Class II Ongoing

LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00

March 25, 2020 Teva Pharmaceuticals USA N/A units

FDA Drug Class II Ongoing

LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00

March 25, 2020 Teva Pharmaceuticals USA N/A units

FDA Drug Class II Ongoing

LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00

March 25, 2020 Teva Pharmaceuticals USA N/A units

FDA Drug Class II Terminated

Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

March 5, 2020 Teva Pharmaceuticals USA 600 cartons/2 auto-injector per carton units

FDA Drug Class II Terminated

Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippa

February 20, 2020 Teva Pharmaceuticals USA 3,695 bottles units

FDA Drug Class III Terminated

Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmace

January 28, 2020 Teva Pharmaceuticals USA 2,044,497 bottles units

FDA Drug Class II Terminated

Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 US

January 27, 2020 Teva Pharmaceuticals USA 22,868 bottles units

FDA Drug Class II Terminated

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01

January 27, 2020 Teva Pharmaceuticals USA 17,436 bottles units

FDA Drug Class II Terminated

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 US

January 27, 2020 Teva Pharmaceuticals USA 69,012 bottles units

FDA Drug Class II Terminated

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01

January 27, 2020 Teva Pharmaceuticals USA

FDA Drug Class III Terminated

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc

September 6, 2019 Teva Pharmaceuticals USA 5,849 bottles units

FDA Drug Class II Ongoing

LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00

June 6, 2019 Teva Pharmaceuticals USA 2,924,000 tablets units

FDA Drug Class II Ongoing

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

June 6, 2019 Teva Pharmaceuticals USA 2,943,000 tablets units

FDA Drug Class II Terminated

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toro

April 12, 2019 Teva Pharmaceuticals USA 171,488 150 mL and 80 mL bottles units

FDA Drug Class III Terminated

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 97774

March 11, 2019 Teva Pharmaceuticals USA 7,081 bottles units

FDA Drug Class II Terminated

Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Ph

December 19, 2018 Teva Pharmaceuticals USA 181,456 bottles units

FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem

November 27, 2018 Teva Pharmaceuticals USA 120,394 bottles units

FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem

November 27, 2018 Teva Pharmaceuticals USA 75,883 bottles units

FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusale

November 27, 2018 Teva Pharmaceuticals USA 142,260 bottles units

FDA Drug Class II Ongoing

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHAR

November 27, 2018 Teva Pharmaceuticals USA 31,079 bottles units

FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusale

November 27, 2018 Teva Pharmaceuticals USA 39,617 bottles units

FDA Drug Class II Ongoing

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHA

November 27, 2018 Teva Pharmaceuticals USA 19,458 bottles units

FDA Drug Class II Ongoing

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHAR

November 27, 2018 Teva Pharmaceuticals USA 37,957 bottles units

FDA Drug Class II Ongoing

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PH

November 27, 2018 Teva Pharmaceuticals USA 41,572 bottles units

FDA Drug Class II Terminated

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Pa

October 19, 2018 Teva Pharmaceuticals USA 53,451 bottles units

FDA Drug Class II Terminated

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02

September 27, 2018 Teva Pharmaceuticals USA 1,362 vials units

FDA Drug Class II Terminated

Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscore

September 21, 2018 Teva Pharmaceuticals USA 313 bottles units

FDA Drug Class II Terminated

Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96

September 20, 2018 Teva Pharmaceuticals USA 1,373 60-count cartons units