Drug product
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
D-1840-2019
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 83497
- Status
- Terminated
- Classification
- Class III
- Quantity
- 648 vials
- Official record key
drug-enforcement:D-1840-2019
Official wording
Reason: Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Code information: Lot #: 101107A, Exp. 10/19.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
out of specification