Medications & Supplements/Prescription Drugs

Pfizer Inc.: Sterile Water for Injection Recalled for Cracked Glass Vials

Agency Publication Date: October 6, 2017

Summary

Approximately 18,725 vials of Sterile Water for Injection, USP Single Dose (100 mL) are being recalled due to reports of cracked or chipped glass at the neck of the vials. This defect can lead to a lack of sterility in the water, which is intended for medical use. Consumers and healthcare facilities should immediately identify if they have the affected lot manufactured by Hospira, Inc. and distributed for Genentech, Inc.

Risk

Cracked or chipped glass compromises the sterile seal of the vial, potentially allowing bacteria or other contaminants to enter the water. If contaminated water is injected into a patient, it could lead to serious, life-threatening infections or other systemic medical complications.

What You Should Do

Check your medical supplies for 100 mL single-dose vials of Sterile Water for Injection, USP labeled with NDC 50242-901-24.
Verify the specific lot number and expiration date on the vial: Look for Lot 63-075-DK with an expiration date of FEB 2019.
If you have this affected lot, stop using the product immediately to avoid the risk of infection from non-sterile water.
Contact your healthcare provider or pharmacist for guidance regarding replacement water or if you have concerns about previous use of this product.
Return any unused vials from this lot to your pharmacy or place of purchase for a refund and contact Pfizer at 1-800-438-1985 for further return instructions.
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

Pharmacist/Healthcare provider consultation and product return.

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

Affected Products

Product: Sterile Water for Injection, USP Single Dose (100 mL)

Model:

NDC 50242-901-24

Recall #: D-1177-2017

Lot Numbers:

63-075-DK (Exp. FEB 2019)

Date Ranges: Expiration February 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78048

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Genentech, Inc.; hospitals; pharmacies; clinics

Manufactured In: United States

Units Affected: 18,725 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 medical supplies for 100 mL single-dose vials of Sterile Water for Injection, USP labeled with NDC 50242-901-24.

Verify the specific lot number and expiration date on the vial: Look for Lot 63-075-DK with an expiration date of FEB 2019.

If you have this affected lot, stop using the product immediately to avoid the risk of infection from non-sterile water.

Contact your healthcare provider or pharmacist for guidance regarding replacement water or if you have concerns about previous use of this product.

Return any unused vials from this lot to your pharmacy or place of purchase for a refund and contact Pfizer at 1-800-438-1985 for further return instructions.

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