FDA Drug recall D-0320-2018
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and N…
- FDA Drug
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and N… by Intrathecal Compounding Specialist, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0320-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-30 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Intrathecal Compounding Specialist |
| Distribution | US |
Product
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Reason
Lack of sterility assurance.
Identifiers
| code_info | All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017) |
|---|
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-0320-2018%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.