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Teva North America Recalls

12 recalls on record · March 9, 2016 to October 12, 2016 · Drugs

October 12, 2016DrugsFDA
Teva North America recalls Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsu
Hazard: Failed Impurities/Degradation Specifications.
September 14, 2016DrugsFDA
Teva North America recalls Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., No
Hazard: CGMP Deviations
September 14, 2016DrugsFDA
Teva North America recalls Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hun
Hazard: CGMP Deviations
September 14, 2016DrugsFDA
Teva North America recalls Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 1
Hazard: CGMP Deviations
September 14, 2016DrugsFDA
Teva North America recalls ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMAC
Hazard: CGMP Deviations
August 31, 2016DrugsFDA
Teva North America recalls Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited
Hazard: Superpotent drug: Out of specification test result for assay during stability testing.
August 17, 2016DrugsFDA
Teva North America recalls Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited,
Hazard: Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
August 10, 2016DrugsFDA
Teva North America recalls Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4
Hazard: Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
August 3, 2016DrugsFDA
Teva North America recalls mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only,
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
August 3, 2016DrugsFDA
Teva North America recalls Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUT
Hazard: Failed Tablet/Capsule Specifications
June 1, 2016DrugsFDA
Teva North America recalls Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Cont
Hazard: Lack of Assurance of Sterility: Due to potential for leaking bags.
March 9, 2016DrugsFDA
Teva North America recalls Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Te
Hazard: Failed Dissolution Specifications: low test results at the 18 month time-point
Teva North America Recalls | RecallWatchUSA