Medications & Supplements/Prescription Drugs

Akorn Inc: Fentanyl Citrate Injection Recalled for Failed Impurity Specifications

Agency Publication Date: April 24, 2019

Summary

Akorn Inc. has voluntarily recalled 5,380 cartons of Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL) because stability testing at the 12-month mark revealed impurity levels of 4.0%, which exceeds the safety limit of 3.0%. Each recalled carton contains 25 glass ampules of the medication. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date affected by this quality failure.

Risk

The presence of impurities above the approved threshold can alter the drug's effectiveness or safety profile. While the risk level is currently considered low, out-of-specification degradation products can potentially cause adverse reactions or lead to insufficient pain management.

What You Should Do

Identify the product by checking the carton for 'Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL)' with NDC 17478-030-25.
Check the packaging for Lot Number 011198 and an Expiration Date of 01/22.
If you have this product, stop using it immediately and quarantine any remaining stock to prevent further use.
Contact your healthcare provider or pharmacist for guidance on alternative medications and to report any issues experienced while using the recalled product.
Return any unused cartons or ampules to the pharmacy or place of purchase for a refund and contact Akorn Inc. for further return instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

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

Affected Products

Product: Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton

Model:

NDC 17478-030-25

Recall #: D-1241-2019

Lot Numbers:

011198 (Exp 01/22)

Date Ranges: Expiration 01/22

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82657

Status: Resolved

Manufacturer: Akorn Inc

Sold By: hospitals; clinics; pharmacies

Manufactured In: United States

Units Affected: 5,380 cartons (25 ampules per carton)

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

Identify the product by checking the carton for 'Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL)' with NDC 17478-030-25.

Check the packaging for Lot Number 011198 and an Expiration Date of 01/22.

If you have this product, stop using it immediately and quarantine any remaining stock to prevent further use.

Contact your healthcare provider or pharmacist for guidance on alternative medications and to report any issues experienced while using the recalled product.

Return any unused cartons or ampules to the pharmacy or place of purchase for a refund and contact Akorn Inc. for further return instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.