FDA-Drug2021-07-14Class I
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
Teva Pharmaceuticals USA
Hazard
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.
Sold states
Distributed Nationwide in the USA
Affected count
10,425 vials
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2021Don't want to check this manually?
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