September 04, 2019
Numerous lots of eptifibatide injection are being recalled by Akorn Inc. because the product is out of specification for the impurity D-aspartic acid, according to the September 4, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following eptifibatide injection products:
- eptifibatide injection, 75 mg/100 mL (0.75 mg/mL), 100-mL single-use vials (NDC 17478-903-90) from lots 091287A and 091377A (Exp. 9/19);
- eptifibatide injection, 75 mg/100 mL (0.75 mg/mL), 100-mL single-use vials (NDC 17478-903-90) from lot 101107A (Exp. 10/19);
- eptifibatide injection, 20 mg/10 mL (2 mg/mL), 10-mL single-use vials (NDC 17478-902-10) from lots 091307A (Exp. 9/19) and 101097A (Exp. 10/19); and
- eptifibatide injection, 200 mg/100 mL (2 mg/mL), 100-mL single-use vials (NDC 17478-902-90), from lot 091277A (Exp. 9/19).
The vials were distributed throughout the United States.
In addition to containing the impurity D-aspartic acid, injections from lot 101107A are just 94 mL, falling short of the 100-mL specification, the FDA stated.
Akorn voluntarily initiated the recall August 6, 2019. The FDA designated the recall Class III August 23, 2019, suggesting use of the affected product is unlikely to cause adverse health consequences.
Eptifibatide injection is an intravenous blood thinner used during heart attack or angioplasty to prevent blood clots.