🔍 RecallPedia

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.

Class I - Dangerous
💊 Drugs Recalled: August 6, 2019 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Akorn, Inc.
Reason for Recall:
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1841-2019

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