Medications & Supplements/Prescription Drugs

Pfizer Inc.: Sodium Bicarbonate Injection Recalled for Glass Particulate Matter

Agency Publication Date: March 29, 2019

Summary

Pfizer Inc. is voluntarily recalling approximately 283,400 vials of 8.4% Sodium Bicarbonate Injection (generic sodium bicarbonate) due to the presence of glass particles inside the vials. This medication is used for electrolyte replacement and to treat metabolic acidosis. The affected products were distributed in 50 mL single-dose fliptop vials across the United States and Puerto Rico. Consumers should stop using the affected lots immediately and contact their healthcare provider or pharmacist for guidance.

Risk

The administration of an injectable drug containing glass particulates can cause local irritation, inflammation, or more serious conditions such as granulomas in the lungs or blockages in blood vessels (embolism), which can be life-threatening.

What You Should Do

Check your medication vials for 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 50 mL single-dose fliptop vials with NDC 0409-6625-02.
Verify the lot numbers and expiration dates on your packaging: look for lot 79-238-EV (Exp. 1 July 2019), lot 79-240-EV (Exp. 1 July 2019), or lot 80-088-EV (Exp. 1 August 2019).
Stop using any products that match these specific lot numbers immediately to avoid the risk of injecting glass particles.
Contact your healthcare provider or pharmacist for guidance if you have been administered this medication or if you have questions about your treatment.
Return any unused product to the pharmacy or place of purchase for a refund and contact Pfizer for further instructions regarding the return process.
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

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

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 50 mL Single-dose fliptop vial

Model:

NDC 0409-6625-02

Lot Numbers:

79-238-EV (Exp. 1 July 2019)

79-240-EV (Exp. 1 July 2019)

80-088-EV (Exp. 1 August 2019)

Date Ranges: Expiration 1 July 2019, Expiration 1 August 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82362

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.

Manufactured In: United States

Units Affected: 283,400 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 medication vials for 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 50 mL single-dose fliptop vials with NDC 0409-6625-02.

Verify the lot numbers and expiration dates on your packaging: look for lot 79-238-EV (Exp. 1 July 2019), lot 79-240-EV (Exp. 1 July 2019), or lot 80-088-EV (Exp. 1 August 2019).

Stop using any products that match these specific lot numbers immediately to avoid the risk of injecting glass particles.

Contact your healthcare provider or pharmacist for guidance if you have been administered this medication or if you have questions about your treatment.

Return any unused product to the pharmacy or place of purchase for a refund and contact Pfizer for further instructions regarding the return process.

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