FDA Drug recall D-0309-2021
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc
- FDA Drug
- Class III
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class III recall of Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc by Teva Pharmaceuticals Usa, citing failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0309-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-03-04 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Reason
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Identifiers
| code_info | Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021 |
|---|
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-0309-2021%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.