Class III
Terminated
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.
- Company
- Akorn, Inc.
- Recall Initiated
- August 6, 2019
- Posted
- September 4, 2019
- Recall Number
- D-1841-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8187 vials
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.
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