Medications & Supplements/Prescription Drugs

Pfizer Inc.: Bacteriostatic Water for Injection Recalled for Lack of Sterility

Agency Publication Date: September 12, 2019

Summary

Pfizer Inc. is recalling 185,700 vials of Bacteriostatic Water for Injection, USP (30 mL) due to a lack of assurance of sterility. This prescription medication, manufactured for Hospira, Inc., is used to dilute or dissolve drugs for injection. The recall affects lot number W20308 with an expiration date of December 1, 2019, and was distributed nationwide across the United States and Puerto Rico.

Risk

A lack of sterility assurance means the product may contain microorganisms like bacteria or fungi. Injecting a non-sterile product can lead to serious, life-threatening infections or localized reactions at the injection site.

What You Should Do

Check your medical supplies for 30 mL vials of Bacteriostatic Water for Injection, USP with the NDC Vial code 0409-3977-01 and NDC Carton code 0409-3977-03.
Verify if your product matches lot number W20308 with an expiration date of Dec 1, 2019.
If you have the affected product, stop using it immediately and do not use it to dilute any other medications.
Contact your healthcare provider or pharmacist for guidance regarding alternative products and to report any concerns.
Return any unused vials to your pharmacy or place of purchase for a refund and contact Pfizer at 1-888-723-3332 for further 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

Drug recall remedy for lack of sterility.

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

Affected Products

Product: Bacteriostatic Water for Injection, USP (30 mL vials)

Model:

NDC Vial: 0409-3977-01

NDC Carton: 0409-3977-03

Recall #: D-1852-2019

Lot Numbers:

W20308 (Exp. Dec 1, 2019)

Date Ranges: Exp. Dec 1, 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83699

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.

Manufactured In: United States

Units Affected: 185,700 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 30 mL vials of Bacteriostatic Water for Injection, USP with the NDC Vial code 0409-3977-01 and NDC Carton code 0409-3977-03.

Verify if your product matches lot number W20308 with an expiration date of Dec 1, 2019.

If you have the affected product, stop using it immediately and do not use it to dilute any other medications.

Contact your healthcare provider or pharmacist for guidance regarding alternative products and to report any concerns.

Return any unused vials to your pharmacy or place of purchase for a refund and contact Pfizer at 1-888-723-3332 for further 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.