FDAFDA · Food and drugs·Recall number D-0661-2021
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
Published July 14, 2021 · Recall initiated: June 18, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # 31328962B, exp. date 04/2022
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.