DrugSep 14, 2016
Teva ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) recall — FDA D-1494-2016
CGMP Deviations
Class IIFDA: TerminatedTeva North America
Recall history in this database
Classification mix: Class II: 5, Class III: 1.
DrugSep 14, 2016
Teva Ondansetron Injection USP 40 mg/20 mL (2 mg/mL) recall — FDA D-1497-2016
CGMP Deviations
Class IIFDA: TerminatedTeva North America
DrugAug 17, 2016
Teva Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle recall — FDA D-1455-2016
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class IIFDA: TerminatedTeva North America
DrugAug 10, 2016
Teva Children's Qnasl 40 mcg recall — FDA D-1453-2016
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class IIIFDA: TerminatedTeva North America
DrugJun 1, 2016
Teva Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31) recall — FDA D-0868-2016
Lack of Assurance of Sterility: Due to potential for leaking bags.
Class IIFDA: TerminatedTeva North America
DrugMar 9, 2016
Capecitabine tablets USP 500 mg, Cytotoxic Agent recall — FDA D-0732-2016
Failed Dissolution Specifications: low test results at the 18 month time-point
Class IIFDA: TerminatedTeva North America
Understanding this recall history
This page summarizes recall records in which the official source identifies Teva North America as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.