FDA Drug recall D-1841-2019
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 Via…
- FDA Drug
- Class III
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class III recall of 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 Via… by Akorn, citing failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1841-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-08-06 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Identifiers
| code_info | Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19. |
|---|
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-1841-2019%22
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