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
Product summary
- 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
Particulate Matter