Teva North America recalls
FDA enforcement reports naming Teva North America as the recalling firm.
- Recall reports
- 12
- Class I (serious)
- 0
- Most recent report
- Oct 12, 2016
- Oct 12, 2016Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Pa…Drug · Teva North AmericaFailed Impurities/Degradation Specifications.Class III
- Sep 14, 2016ARGATROBAN Injection in 0Drug · Teva North AmericaCGMP DeviationsClass II
- Sep 14, 2016Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for T…Drug · Teva North AmericaCGMP DeviationsClass II
- Sep 14, 2016Eptifibatide Injection 75 mg/100 mL (0Drug · Teva North AmericaCGMP DeviationsClass II
- Sep 14, 2016Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTI…Drug · Teva North AmericaCGMP DeviationsClass II
- Aug 31, 2016Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured…Drug · Teva North AmericaSuperpotent drug: Out of specification test result for assay during stability testing.Class II
- Aug 17, 2016Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by…Drug · Teva North AmericaPresence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.Class II
- Aug 10, 2016Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray,…Drug · Teva North AmericaFailed Content Uniformity Specifications: out of specification test result for spray content uniformity.Class III
- Aug 3, 2016mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vi…Drug · Teva North AmericaFailed Impurities/Degradation Specifications: High out of specification results for Impurity D.Class III
- Aug 3, 2016Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactu…Drug · Teva North AmericaFailed Tablet/Capsule SpecificationsClass III
- Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packag…
- Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manu…
Page 1 of 2