Medications & Supplements/Prescription Drugs

XELLIA PHARMACEUTICALS USA, LLC: Micafungin for Injection Recalled Due to Incomplete Package Insert

Agency Publication Date: August 20, 2021

Summary

Xellia Pharmaceuticals USA, LLC is recalling approximately 18,322 vials of Micafungin for Injection (50 mg and 100 mg dosages) because the package insert provided with the medication is missing mandatory safety sections. Specifically, the insert fails to include crucial information regarding Adverse Reactions, Drug Interactions, and Use in Specific Populations. This product is a prescription medication used for intravenous infusion and was distributed nationwide across the United States.

Risk

The omission of safety data regarding drug interactions and side effects could lead to healthcare providers or patients being unaware of serious risks, potentially resulting in improper medical management or unrecognized adverse health events.

What You Should Do

Check your medical supplies for Micafungin for Injection vials with lot number 467111 and an expiration date of January 2023 (1/2023).
Confirm if your product is affected by checking the NDC numbers on the vial: NDC 70594-036-01 for the 50 mg dosage or NDC 70594-037-01 for the 100 mg dosage.
Contact your healthcare provider or pharmacist immediately if you have this medication to determine if your treatment is affected or if you require a replacement.
Return any unused vials from the affected lot to the pharmacy or place of purchase for a full refund.
Contact Xellia Pharmaceuticals USA, LLC at their Buffalo Grove, IL facility or via the contact information provided on their official website for further instructions regarding this recall.
For additional questions or to report a side effect, 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

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Micafungin for Injection (50 mg/vial)

Model:

NDC 70594-036-01

Recall #: D-0756-2021

Lot Numbers:

467111 (Exp 1/2023)

Date Ranges: January 2023

Product: Micafungin for Injection (100 mg/vial)

Model:

NDC 70594-037-01

Recall #: D-0757-2021

Lot Numbers:

467111 (Exp 1/2023)

Date Ranges: January 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88457

Status: Resolved

Manufacturer: XELLIA PHARMACEUTICALS USA, LLC

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: United States

Units Affected: 2 products (9,161 vials 50 mg and 100 mg vials total; 9,161 (50mg and 100 mg vials total))

Distributed To: Nationwide

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

Check your medical supplies for Micafungin for Injection vials with lot number 467111 and an expiration date of January 2023 (1/2023).

Confirm if your product is affected by checking the NDC numbers on the vial: NDC 70594-036-01 for the 50 mg dosage or NDC 70594-037-01 for the 100 mg dosage.

Contact your healthcare provider or pharmacist immediately if you have this medication to determine if your treatment is affected or if you require a replacement.

Return any unused vials from the affected lot to the pharmacy or place of purchase for a full refund.

Contact Xellia Pharmaceuticals USA, LLC at their Buffalo Grove, IL facility or via the contact information provided on their official website for further instructions regarding this recall.

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