FDA-Drug2019-09-04Class III
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.
Akorn, Inc.
Hazard
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.
Sold states
Nationwide in the U.S.
Affected count
648 vials
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1840-2019Don't want to check this manually?
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