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
Recalled September 14, 2016 · FDA recall D-1497-2016 · Teva North America
Hazard
CGMP Deviations · FDA Class II
Units
13,223 vials
Sold at
Nationwide and Puerto Rico
Description
CGMP Deviations
Product
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
Manufacturer(s)
Teva North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →