Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
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.
Lot numbers, UPCs & expiration codes
Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1841-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 6, 2019
- FDA report date
- Sep 4, 2019
- Quantity
- 8187 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1841-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 83497
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.
- Postal code
- 60045-4862
- Report date
- Sep 4, 2019
- Product type
- Drugs
- Recall number
- D-1841-2019
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 8187 vials
- Termination date
- Jul 28, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Aug 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 23, 2019