Question 1

Is Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02 recalled?

Accepted Answer

Akorn Inc. has voluntarily recalled 15,170 ampules of Fentanyl Citrate Injection, USP (100 mcg/2 mL). This recall was issued because laboratory testing found that the total impurity level in the medication was 4.1%, which is higher than the approved safety limit of 3.0%. About 15,170 units are affected by this issue, which was discovered during routine testing of retained samples. Consumers should contact their doctor or pharmacist regarding any products from the affected lot, as the degradation of the medication may impact its performance.

Question 2

What should I do?

Accepted Answer

Check your medication to see if you have Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL) in 2 mL ampules. Verify if your product is affected by looking for NDC 17478-030-02 and Lot 081887A with an expiration date of 08/2021 on the carton or ampule. If you have the affected product, contact your healthcare provider or pharmacist for guidance on whether you should continue use or seek an alternative. Return any unused product from Lot 081887A to the pharmacy where it was purchased for a refund. Contact Akorn Inc. directly at their Lake Forest, Illinois office for further instructions on returning the product and receiving credit. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

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

Akorn Inc: Fentanyl Citrate Injection Recalled Due to Excessive Impurities

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information