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Recall Observatory FDA recall evidence

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

August 06, 2019

Class III

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

    reason.potency_specification_failure · v1.0.0

    out of specification