Medications & Supplements/Prescription Drugs

Akorn, Inc.: Eptifibatide Injection Recalled for Impurities and Incorrect Fill Volume

Agency Publication Date: August 23, 2019

Summary

Akorn, Inc. is recalling approximately 12,920 vials of Eptifibatide Injection, a medication used for heart-related conditions. The recall was initiated because some vials were found to have levels of an impurity called D-aspartic acid that exceed safety specifications, and one specific lot was also found to be 'short-filled' with only 94 mL of liquid instead of the required 100 mL. These issues were discovered during routine stability testing and quality control inspections. Consumers should immediately check their medication for the affected lot numbers and contact their healthcare provider or pharmacist regarding the next steps for their treatment.

Risk

The presence of impurities above specified limits can potentially alter the effectiveness of the drug or cause unintended side effects, while a short-filled vial may result in a patient receiving an incorrect dose of the medication.

What You Should Do

Check your medication vials for Eptifibatide Injection to see if they match the following affected NDC numbers and lot information: NDC 17478-903-90 (Lots 091287A, 091377A, 101107A); NDC 17478-902-10 (Lots 091307A, 101097A); or NDC 17478-902-90 (Lot 091277A).
Verify the expiration dates on your vials; affected products have expiration dates of September 2019 (9/19) or October 2019 (10/19).
If you have any of the affected lots, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment and to arrange for a replacement.
Return any unused vials from the recalled lots to the pharmacy where they were purchased to receive a refund.
Contact Akorn, Inc. at their Lake Forest, IL headquarters if you have further questions regarding the return process.
For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Pharmacist or Healthcare Provider Consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial

Model:

NDC 17478-903-90

Lot Numbers:

091287A (Exp. 9/19)

091377A (Exp. 9/19)

Date Ranges: Expiration 9/19

Product: Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial (Short Fill)

Model:

NDC 17478-903-90

Lot Numbers:

101107A (Exp. 10/19)

Date Ranges: Expiration 10/19

Product: Eptifibatide Injection, 20 mg/10 mL (2 mg/mL), 10 mL Single Use Vial

Model:

NDC 17478-902-10

Lot Numbers:

091307A (Exp. 9/19)

101097A (Exp. 10/19)

Date Ranges: Expiration 9/19, Expiration 10/19

Product: Eptifibatide Injection, 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial

Model:

NDC 17478-902-90

Lot Numbers:

091277A (Exp. 9/19)

Date Ranges: Expiration 9/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83497

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Hospitals; Pharmacies

Manufactured In: United States

Units Affected: 3 products (4085 vials; 648 vials; 8187 vials)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vials for Eptifibatide Injection to see if they match the following affected NDC numbers and lot information: NDC 17478-903-90 (Lots 091287A, 091377A, 101107A); NDC 17478-902-10 (Lots 091307A, 101097A); or NDC 17478-902-90 (Lot 091277A).

Verify the expiration dates on your vials; affected products have expiration dates of September 2019 (9/19) or October 2019 (10/19).

If you have any of the affected lots, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment and to arrange for a replacement.

Return any unused vials from the recalled lots to the pharmacy where they were purchased to receive a refund.

Contact Akorn, Inc. at their Lake Forest, IL headquarters if you have further questions regarding the return process.

For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial

Model:

NDC 17478-903-90

Lot Numbers:

091287A (Exp. 9/19)

091377A (Exp. 9/19)

Date Ranges: Expiration 9/19

Product: Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial (Short Fill)

Model:

NDC 17478-903-90

Lot Numbers:

101107A (Exp. 10/19)

Date Ranges: Expiration 10/19

Product: Eptifibatide Injection, 20 mg/10 mL (2 mg/mL), 10 mL Single Use Vial

Model:

NDC 17478-902-10

Lot Numbers:

091307A (Exp. 9/19)

101097A (Exp. 10/19)

Date Ranges: Expiration 9/19, Expiration 10/19

Product: Eptifibatide Injection, 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial

Model:

NDC 17478-902-90

Lot Numbers:

091277A (Exp. 9/19)

Date Ranges: Expiration 9/19