FDA Drug recall D-0661-2021
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc
- FDA Drug
- Class I
- terminated
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class I recall of Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc by Teva Pharmaceuticals Usa, citing 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 we….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0661-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-06-18 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot # 31328962B, exp. date 04/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0661-2021%22
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