Medications & Supplements/Prescription Drugs

Mylan Institutional LLC: Daptomycin for Injection Recalled Due to Particulate Matter

Agency Publication Date: August 4, 2020

Summary

Mylan Institutional LLC is recalling 18,480 vials of Daptomycin for Injection (500 mg/vial). This prescription antibiotic was found to contain particulate matter, which are unintended particles present in the medication vial. If these particles are injected into a patient's bloodstream, they can cause serious medical complications including local irritation, inflammation, or the blockage of blood vessels. Consumers who have this medication should check their supply immediately.

Risk

The presence of particulate matter in an injectable drug can lead to the formation of blood clots or embolisms that travel to vital organs like the lungs, heart, or brain, potentially causing life-threatening injury.

What You Should Do

Check your medication vials for Daptomycin for Injection, 500 mg/vial, with NDC 67457-813-50.
Specifically look for Lot Number 7605112 with an expiration date of 10/2021 printed on the label.
If you have the affected medication, stop using it immediately and do not administer it to any patient.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse health effects.
Return any unused product from the affected lot to your pharmacy for a refund and contact Mylan Institutional LLC for further instructions.
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.

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: Daptomycin for Injection (500 mg/vial)

Model:

NDC 67457-813-50

Recall #: D-1484-2020

Lot Numbers:

7605112 (Exp 10/2021)

Date Ranges: Expiration 10/2021

Product Images

Photo 1 – Labeling, Daptomycin for Injection 500 mg/vial

Photo 2 - Labeling, Daptomycin for Injection 500 mg/vial

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85956

Status: Resolved

Manufacturer: Mylan Institutional LLC

Sold By: hospitals; pharmacies

Manufactured In: United States

Units Affected: 18,480 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 · FDA Press Release · 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 medication vials for Daptomycin for Injection, 500 mg/vial, with NDC 67457-813-50.

Specifically look for Lot Number 7605112 with an expiration date of 10/2021 printed on the label.

If you have the affected medication, stop using it immediately and do not administer it to any patient.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse health effects.

Return any unused product from the affected lot to your pharmacy for a refund and contact Mylan Institutional LLC for further instructions.

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.