Home / Recalls / Akorn, Inc. / D-1840-2019

D-1840-2019 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
September 4, 2019
Initiation Date
August 6, 2019
Termination Date
July 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
648 vials

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #: 101107A, Exp. 10/19.

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