Recalls / Class III
Class IIID-1841-2019
Product
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.
- Affected lot / code info
- Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 8187 vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-08-06
- FDA classified
- 2019-08-23
- Posted by FDA
- 2019-09-04
- Terminated
- 2022-07-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1841-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.