FDA Drug recall D-0765-2022
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc.…
- FDA Drug
- Class I
- terminated
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class I recall of IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc.… by Teva Pharmaceuticals Usa, citing presence of Particulate Matter: Product was found to contain silica and iron oxide.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0765-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-03-29 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Identifiers
| code_info | Lot #: 31329657B, Exp. Date 08/2023 |
|---|
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-0765-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.