Medications & Supplements/Prescription Drugs

Pfizer Inc.: Sterile Water for Injection Recalled Due to Insect Found in Vial

Agency Publication Date: May 14, 2021

Summary

Pfizer Inc. has recalled approximately 49,525 vials of Sterile Water for Injection, USP (100 mL Single Dose Vials). The recall was initiated after a foreign object, specifically identified as an insect, was discovered inside one of the vials. This product is typically used by healthcare professionals to dilute or dissolve drugs before they are injected into patients. If you or a family member are using this product at home for medical treatments, you should check your supply immediately for the affected lot number DN9185.

Risk

The presence of an insect in a sterile injectable product constitutes serious contamination that can lead to life-threatening infections, inflammation, or allergic reactions if the fluid is administered to a patient. While only one vial was reported to contain an insect, the entire lot is considered compromised.

What You Should Do

Check your medical supplies for 100 mL Single Dose Vials of Sterile Water for Injection, USP, distributed by Hospira, Inc. and manufactured by Pfizer.
Locate the lot number on the vial or the carton; this recall specifically affects Lot DN9185 with NDC Carton 0409-4887-99 and NDC Vial 0409-4887-25.
Stop using any product from Lot DN9185 immediately to prevent the risk of injecting contaminated fluid.
Contact your healthcare provider or pharmacist immediately for guidance on obtaining a safe replacement and to report if the product has already been used.
Return any unused vials from the affected lot to the pharmacy or place of purchase for a full refund.
Contact Pfizer Inc. at 1-888-723-3332 for further instructions regarding the return process or if you have technical questions.
For additional questions or to report a complaint, call 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: Sterile Water for Inj., USP (100 mL Single Dose Vials)

Model:

NDC Carton: 0409-4887-99

NDC Vial: 0409-4887-25

Recall #: D-0384-2021

Lot Numbers:

DN9185

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87831

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.; Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 49,525 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

Risk

What You Should Do

Check your medical supplies for 100 mL Single Dose Vials of Sterile Water for Injection, USP, distributed by Hospira, Inc. and manufactured by Pfizer.

Locate the lot number on the vial or the carton; this recall specifically affects Lot DN9185 with NDC Carton 0409-4887-99 and NDC Vial 0409-4887-25.

Stop using any product from Lot DN9185 immediately to prevent the risk of injecting contaminated fluid.

Contact your healthcare provider or pharmacist immediately for guidance on obtaining a safe replacement and to report if the product has already been used.

Return any unused vials from the affected lot to the pharmacy or place of purchase for a full refund.

Contact Pfizer Inc. at 1-888-723-3332 for further instructions regarding the return process or if you have technical questions.

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