Eptifibatide Injection — Class III drug recall D-1841-2019
Terminated recall by Akorn, Inc., reported 2019-09-04, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
| Recall number | D-1841-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2019-08-06 |
| Classified | 2019-08-23 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 8,187 vials |
| Reason classes | specification failure |
| NDC | 17478-0902-10, 17478-0902-90 |
Product
Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
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-1841-2019. 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.