Akorn, Inc. recalls Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactu…

Recall date

August 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1840-2019

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the U.S.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.