Topotecan Injection 4 mg/4mL — Class I drug recall D-0661-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2021-07-14, distributed nationwide. Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was
| Recall number | D-0661-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-06-18 |
| Classified | 2021-07-15 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2022-04-04 |
| Distributed | Nationwide (US) |
| Quantity | 10,425 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00703-4714-01, 00703-4714-71 |
| Lot numbers | 31328962B |
| Expiration dates | 2022-04 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0661-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.