Medications & Supplements/Prescription Drugs

MERCK SHARP & DOHME CORP: Cubicin (daptomycin for injection) Recalled for Glass Particles

Agency Publication Date: November 3, 2021

Summary

Merck Sharp & Dohme Corp. is recalling 76,163 vials of Cubicin (daptomycin for injection), 500 mg per vial, due to the presence of particulate matter identified as glass particles. This injectable antibiotic was manufactured by Baxter Pharmaceuticals and distributed nationwide across the United States. Consumers should be aware that this is a critical risk level recall for a prescription drug designed for intravenous use.

Risk

The administration of an injectable drug containing glass particles can cause serious health risks, including local irritation or inflammation, and more severe complications such as granuloma, embolism, or life-threatening systemic inflammation if the particles travel through the bloodstream.

What You Should Do

Identify the affected medication by checking the vial and packaging for Cubicin (daptomycin for injection), 500 mg per vial, with NDC number 67919-011-01.
Check for Lot #: 934778 with an Expiration Date of Jun 2022. This specific lot is the only one affected by this recall.
If you have this specific lot, stop using the product immediately and do not administer it to patients.
Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to report any adverse health effects.
Return any unused product from the affected lot to your pharmacy or the place of purchase for a refund and further instructions.
Contact Merck Sharp & Dohme Corp. or the manufacturer, Baxter Pharmaceuticals LLC, for further details regarding the return process.
For additional questions or to report a complaint, 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

Contact healthcare provider and return product

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

Affected Products

Product: Cubicin (daptomycin for injection), 500 mg per vial

Model:

NDC: 67919-011-01

Recall #: D-0093-2022

Lot Numbers:

934778 (Exp. Date Jun 2022)

Date Ranges: Jun 2022

Product Images

“Image of Cubicin 500mg”

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88867

Status: Resolved

Manufacturer: MERCK SHARP & DOHME CORP

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 76,163 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

Identify the affected medication by checking the vial and packaging for Cubicin (daptomycin for injection), 500 mg per vial, with NDC number 67919-011-01.

Check for Lot #: 934778 with an Expiration Date of Jun 2022. This specific lot is the only one affected by this recall.

If you have this specific lot, stop using the product immediately and do not administer it to patients.

Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to report any adverse health effects.

Return any unused product from the affected lot to your pharmacy or the place of purchase for a refund and further instructions.

Contact Merck Sharp & Dohme Corp. or the manufacturer, Baxter Pharmaceuticals LLC, for further details regarding the return process.

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