Drug 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.
D-1841-2019
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 83497
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8187 vials
- Official record key
drug-enforcement:D-1841-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Code information: Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Out of Specification