Teva Pharmaceuticals USA recalls Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton…

Recall date

June 18, 2021

Source

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

Recall number

D-0661-2021

FDA classification

Class I

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71