Ondansetron Injection USP 40 mg/ recalled over manufacturing violations

Recall date

June 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teva North America recalls Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., N…

Recall number

D-1497-2016

FDA classification

Class II

Brand / firm

Teva North America

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)