Teva North America

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0005-2017Class IIIClaravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 CapAugust 5, 2016
D-1453-2016Class IIIChildren's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered SpJuly 15, 2016
D-1470-2016Class IIAmoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by:June 24, 2016
D-1455-2016Class IIAlbuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract PharJune 22, 2016
D-1496-2016Class IIEptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only,June 17, 2016
D-1494-2016Class IIARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in HungJune 17, 2016
D-1495-2016Class IILinezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INCJune 17, 2016
D-1497-2016Class IIOndansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUJune 17, 2016
D-1451-2016Class IIImitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged iMay 31, 2016
D-1449-2016Class IIIDivalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in IsraelMay 18, 2016
D-0868-2016Class IILinezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 30April 27, 2016
D-0732-2016Class IICapecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in CDecember 21, 2015