Reported Sep 4, 2019 · 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),…
Akorn, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
Eptifibatide Injectiona) 20 mg/10 mL (2 mg/mL)10 mL Single Use VialNDC 17478-902-10b) 200 mg/100 mL (2 mg/mL)100 mL Single-use VialNDC 17478-902-90For Intravenous Use OnlyRx Only
- Manufactured byAkorn Inc., Lake Forest, IL 60045
- Lot codes and dates
Lot #s: a) 091307AExp. 9/19101097AExp. 10/19b) 091277AExp. 9/19
- Amount recalled
- 8187 vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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