Medications & Supplements/Prescription Drugs

Astellas Pharma US Inc: Mycamine (micafungin) for Injection Recalled for Labeling Error on Strength

Agency Publication Date: February 4, 2018

Summary

Astellas Pharma US Inc is recalling 63,600 vials of Mycamine (micafungin) for Injection 100 mg/vial due to a labeling error regarding the declared strength on the product. This prescription antifungal medication, used to treat various fungal infections, may have incorrect dosage information on the label which could lead to medication errors. Consumers who have this medication should check their lot numbers immediately and consult their healthcare provider or pharmacist.

Risk

The labeling error on the declared strength can lead to healthcare providers administering the wrong dose of medication. An incorrect dose of micafungin could result in under-treatment of a serious fungal infection or potential side effects from over-dosage.

What You Should Do

Check your Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vials for the following lot numbers and expiration dates: Lot F1700164 (Exp. 02/20) or Lot A000000220 (Exp. 06/20).
Locate the NDC number 0469-3211-10 on the product packaging to confirm it matches the recalled units.
If you identify an affected vial, do not use the medication and contact your healthcare provider or pharmacist immediately for guidance on a replacement.
Return any unused product from the affected lots to your pharmacy for a refund or further instructions.
Contact Astellas Pharma US Inc at 1-888-723-3332 if you have specific questions regarding this recall or the product's quality.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.

Your Remedy Options

Full Refund

Contact healthcare provider and return to pharmacy

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

Affected Products

Product: Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial

Model:

NDC 0469-3211-10

Recall #: D-0548-2018

Lot Numbers:

F1700164 (Exp. 02/20)

A000000220 (Exp. 06/20)

Date Ranges: Expiration 02/2020, Expiration 06/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78981

Status: Resolved

Manufacturer: Astellas Pharma US Inc

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 63600 vials

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 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vials for the following lot numbers and expiration dates: Lot F1700164 (Exp. 02/20) or Lot A000000220 (Exp. 06/20).

Locate the NDC number 0469-3211-10 on the product packaging to confirm it matches the recalled units.

If you identify an affected vial, do not use the medication and contact your healthcare provider or pharmacist immediately for guidance on a replacement.

Return any unused product from the affected lots to your pharmacy for a refund or further instructions.

Contact Astellas Pharma US Inc at 1-888-723-3332 if you have specific questions regarding this recall or the product's quality.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.