FDA Drug recall D-0711-2020
BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- FDA Drug
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 by Assurance Infusion, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0711-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-20 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Assurance Infusion |
| Distribution | US |
Product
BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason
Lack of sterility assurance.
Identifiers
| code_info | Lots: 12112019@5 Exp. 12/20/2019 |
|---|
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-0711-2020%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.