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Recall Observatory FDA recall evidence

Drug product

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

D-0661-2021

June 18, 2021

Class I

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 88154
Status
Terminated
Classification
Class I
Quantity
10,425 vials
Official record key
drug-enforcement:D-0661-2021

Official wording

Reason: 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.

Code information: Lot # 31328962B, exp. date 04/2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter