Teva Pharmaceuticals USA, Inc.

Sellersville, PA, United States

69

Total Recalls

2

Class I Recalls

14

Ongoing Recalls

Recalls by Teva Pharmaceuticals USA, Inc.

FDA Drug Class III Terminated

Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58

March 15, 2013 Teva Pharmaceuticals USA, Inc. 47,200 blister packs units
FDA Drug Class III Terminated

Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67

March 15, 2013 Teva Pharmaceuticals USA, Inc. 148,785 blister packs units
FDA Drug Class III Terminated

Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sel

March 15, 2013 Teva Pharmaceuticals USA, Inc. 54,412 blister packs units
FDA Drug Class III Terminated

Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58

March 15, 2013 Teva Pharmaceuticals USA, Inc. 154,536 cartons units
FDA Drug Class III Terminated

Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58

March 15, 2013 Teva Pharmaceuticals USA, Inc. 59,240 Cartons units
FDA Drug Class III Terminated

Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA,

March 14, 2013 Teva Pharmaceuticals USA, Inc. 17,108 blister packs units
FDA Drug Class III Terminated

Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser

March 14, 2013 Teva Pharmaceuticals USA, Inc. 120,049 blister packs units
FDA Drug Class III Terminated

Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratori

March 12, 2013 Teva Pharmaceuticals USA, Inc. 71,893 dispensers units
FDA Drug Class III Terminated

Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per

March 12, 2013 Teva Pharmaceuticals USA, Inc. 17,661 blister cards units
FDA Drug Class II Terminated

Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.

February 26, 2013 Teva Pharmaceuticals USA, Inc. 62,187 bottles units
FDA Drug Class II Terminated

CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96

February 7, 2013 Teva Pharmaceuticals USA, Inc. 3 boxes units
FDA Drug Class II Terminated

Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd.

January 23, 2013 Teva Pharmaceuticals USA, Inc. 3,913 bottles units
FDA Drug Class II Terminated

Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; D

December 5, 2012 Teva Pharmaceuticals USA, Inc. 6,692 boxes units
FDA Drug Class II Terminated

Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30

May 18, 2012 Teva Pharmaceuticals USA, Inc. 6,647 cartons units
FDA Drug Class II Terminated

Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville,

May 16, 2012 Teva Pharmaceuticals USA, Inc. 2,268 bottles units
FDA Drug Class II Terminated

Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceutical

May 2, 2012 Teva Pharmaceuticals USA, Inc. 100,761 cartons units
FDA Drug Class III Terminated

CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88

April 24, 2012 Teva Pharmaceuticals USA, Inc. 13,232 bottles units
FDA Drug Class III Terminated

Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc.,

April 23, 2012 Teva Pharmaceuticals USA, Inc. 40,750 Dispensers units
FDA Drug Class II Terminated

Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dos

April 2, 2012 Teva Pharmaceuticals USA, Inc. 4188 cartons (5 X 5 blisterpacks) units