Medications & Supplements/Prescription Drugs

Fagron Sterile Services Fentanyl Citrate IV Bags Recalled for Sterility Concerns

Agency Publication Date: February 19, 2025

Summary

Fagron Compounding Services is recalling 1,330 bags of fentanyl citrate in sodium chloride (1600mcg/100mL) IV solution. The recall was initiated because the company cannot guarantee the sterility of the single-use 100mL IV bags. These medical products were distributed to healthcare facilities specifically within Pennsylvania.

Risk

A lack of assurance of sterility in an intravenous medication poses a significant risk of infection to patients. If a non-sterile product is administered directly into the bloodstream, it can lead to serious and potentially life-threatening systemic infections.

What You Should Do

This recall affects fentanyl citrate in sodium chloride 1600mcg/100mL (16 mcg per mL) IV bags sold in 100mL single-use containers under the Fagron Sterile Services brand.
Identify the affected products by checking for lot number C274-000040409 with an expiration date of 03/22/2025 and Bar Code (NDC) 71266-5060-01.
Stop using the recalled product immediately. Contact Fagron Compounding Services or your medical distributor to arrange for the return of any remaining units.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information regarding this safety alert.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Fentanyl Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) IV Bagby Fagron Sterile Services

Variants: Single use 100mL IV Bag, 1600mcg/100mL

Lot Numbers:

C274-000040409 (Exp 03/22/2025)

NDC:

71266-5060-01

Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96232

Status: Resolved

Manufacturer: Fagron Compounding Services

Sold By: Hospitals; Clinics; Wholesalers; Healthcare facilities

Manufactured In: United States

Units Affected: 1330 bags

Distributed To: Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

This recall affects fentanyl citrate in sodium chloride 1600mcg/100mL (16 mcg per mL) IV bags sold in 100mL single-use containers under the Fagron Sterile Services brand.

Identify the affected products by checking for lot number C274-000040409 with an expiration date of 03/22/2025 and Bar Code (NDC) 71266-5060-01.

Stop using the recalled product immediately. Contact Fagron Compounding Services or your medical distributor to arrange for the return of any remaining units.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information regarding this safety alert.