FDA Recall D-0661-2021
Teva Pharmaceuticals USA · Parsippany, NJ
Class I — life-threatening Terminated 290 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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.
Recall record
- Recall number
D-0661-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2021-06-18
- Classified by FDA Center
- 2021-07-15
- FDA published
- 2021-07-14
- Terminated
- 2022-04-04
- Recalling firm
- Teva Pharmaceuticals USA
- Firm location
- Parsippany, NJ