Medications & Supplements/Prescription Drugs

PFIZER: Daptomycin for Injection Recalled for Potential Microbial Contamination

Agency Publication Date: August 2, 2018

Summary

Pfizer is recalling approximately 234,680 vials of Daptomycin for Injection (500 mg per vial), an intravenous antibiotic used to treat bacterial infections. This recall was initiated after reports of adverse events, including infusion reactions, which may be linked to microbial contamination within the sterile product. Affected vials were distributed nationwide across the United States and Puerto Rico under the Hospira, Inc. brand.

Risk

The presence of microbes in a sterile injectable drug can lead to serious health complications, including life-threatening infections or severe infusion-related reactions. Pfizer has received reports of adverse events indicative of such reactions related to this contamination.

What You Should Do

Check your supply for Hospira brand Daptomycin for Injection, 500 mg per vial (NDC 0409-0106-01), packaged as a single-dose vial in a carton.
Verify the lot numbers and expiration dates on the vial or carton: 712453A (Exp 1-Nov-18), 771803A (Exp 1-May-19), 792103A (Exp 1-Jul-19), 800903A (Exp 1-Aug-19), 810853A (Exp 1-Sep-19), 841703A (Exp 1-Dec-19), 841753A (Exp 1-Dec-19), or 850553A (Exp 1-Jan-20).
Immediately stop using any product from the affected lots and quarantine the supply to prevent further use.
Contact your healthcare provider or pharmacist immediately if you have used this product and are experiencing any unusual symptoms or health concerns.
Return any unused product from the affected lots to your pharmacy or place of purchase for a refund.
Contact Pfizer/Hospira directly at the distributor address (275 N Field Dr, Lake Forest, Illinois) or through their official channels for specific instructions on returning the product.
For additional questions, 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

Pharmacy refund and healthcare consultation

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 per vial)

Model:

NDC 0409-0106-01

Lot Numbers:

712453A (Exp 1-Nov-18)

771803A (Exp 1-May-19)

792103A (Exp 1-Jul-19)

800903A (Exp 1-Aug-19)

810853A (Exp 1-Sep-19)

841703A (Exp 1-Dec-19)

841753A (Exp 1-Dec-19)

850553A (Exp 1-Jan-20)

Date Ranges: 1-Nov-18, 1-May-19, 1-Jul-19, 1-Aug-19, 1-Sep-19, 1-Dec-19, 1-Jan-20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80399

Status: Resolved

Manufacturer: PFIZER

Sold By: Hospira, Inc.; Hospitals; Clinics

Manufactured In: United States

Units Affected: 234,680 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 supply for Hospira brand Daptomycin for Injection, 500 mg per vial (NDC 0409-0106-01), packaged as a single-dose vial in a carton.

Verify the lot numbers and expiration dates on the vial or carton: 712453A (Exp 1-Nov-18), 771803A (Exp 1-May-19), 792103A (Exp 1-Jul-19), 800903A (Exp 1-Aug-19), 810853A (Exp 1-Sep-19), 841703A (Exp 1-Dec-19), 841753A (Exp 1-Dec-19), or 850553A (Exp 1-Jan-20).

Immediately stop using any product from the affected lots and quarantine the supply to prevent further use.

Contact your healthcare provider or pharmacist immediately if you have used this product and are experiencing any unusual symptoms or health concerns.

Return any unused product from the affected lots to your pharmacy or place of purchase for a refund.

Contact Pfizer/Hospira directly at the distributor address (275 N Field Dr, Lake Forest, Illinois) or through their official channels for specific instructions on returning the product.

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