FDA Drug recall D-0432-2024
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minne…
- FDA Drug
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minne… by Integradose Compounding Services, citing lack of Assurance of Sterility: leaking bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0432-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-22 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Integradose Compounding Services |
| Distribution | US |
Product
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Reason
Lack of Assurance of Sterility: leaking bags
Identifiers
| code_info | Lot#: 20231020FEN-1, Exp: 04/17/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0432-2024%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.