Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
Reported: September 4, 2019 Initiated: August 6, 2019 #D-1840-2019
Product Description
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
Reason for Recall
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 648 vials
- Distribution
- Nationwide in the U.S.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.. Recalled by Akorn, Inc.. Units affected: 648 vials.
Why was this product recalled? ▼
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and 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-1840-2019.
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