RecallDepth
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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