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.
Reported: September 4, 2019 Initiated: August 6, 2019 #D-1841-2019
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 8187 vials
- Distribution
- Nationwide in the U.S.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn, Inc.. Units affected: 8187 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 4, 2019. Severity: Low. Recall number: D-1841-2019.
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