All sterile drug preparations remaining within expiry prepared from… — Class II drug recall D-0323-2018
Terminated recall by Intrathecal Compounding Specialist, LLC, reported 2018-02-14, distributed nationwide. Lack of sterility assurance.
| Recall number | D-0323-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intrathecal Compounding Specialist, LLC, Scott, LA, United States |
| Recall initiated | 2017-11-30 |
| Classified | 2018-02-04 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
Product
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Reason for recall
Lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0323-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.