IDArubicin Hydrochloride Injection USP 5gm/5mL — Class I drug recall D-0765-2022
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2022-04-20, distributed nationwide. Presence of Particulate Matter: Product was found to contain silica and iron oxide
| Recall number | D-0765-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2022-03-29 |
| Classified | 2022-04-11 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2023-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,565 vials |
| Reason classes | specification failure |
| NDC | 00703-4154-11 |
| Lot numbers | 31329657B |
| Expiration dates | 2023-08 |
Product
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
Reason for recall
Presence of Particulate Matter: Product was found to contain silica and iron oxide
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-0765-2022. 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.