D-0661-2021 Class I Terminated
FDA drug recall D-0661-2021 was initiated by Teva Pharmaceuticals USA on June 18, 2021 and is designated Class I. 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 identifi… The recall status is terminated (terminated April 4, 2022). Affected quantity: 10,425 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 14, 2021
- Initiation Date
- June 18, 2021
- Termination Date
- April 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,425 vials
Product Description
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # 31328962B, exp. date 04/2022