FDA-Drug2019-09-04Class III
Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
Akorn, Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Sold states
Nationwide in the U.S.
Affected count
8187 vials
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1841-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief