Class I
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- June 18, 2021
- Posted
- July 14, 2021
- Recall Number
- D-0661-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,425 vials
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
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.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot # 31328962B, exp. date 04/2022
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