Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Bupivacaine Hydrochloride Injection Recalled for Particulate Matter Contamination

Agency Publication Date: November 12, 2020

Summary

Baxter Healthcare Corporation is recalling three lots of Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) because black and transparent particles were found in the solution. This medication is a prescription local anesthetic used for spinal anesthesia. The presence of particles in an injectable drug can lead to serious health complications, such as inflammation or damage to blood vessels and organs. These products were distributed nationwide in the United States in packs of 10 single-dose ampules.

Risk

Injecting a solution containing particulate matter can cause local inflammation, blockages in blood vessels, or systemic toxicity as the particles travel through the bloodstream. This poses a particular risk in spinal applications where it could lead to tissue damage or serious neurological complications.

What You Should Do

Check your medication supply for Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) in 10 x 2 mL single-dose ampules with NDC 36000-092-10.
Specifically look for the following affected lot numbers and expiration dates: Lot A0B1241 (Exp 10/2020), Lot A0C0091 (Exp 12/2020), and Lot A0D0268 (Exp 02/2022).
If you have an affected product, stop using it immediately and quarantine the units to prevent accidental use.
Contact your healthcare provider or pharmacist immediately for guidance if you have been administered this product or if you have it in your possession.
Return any unused product to the pharmacy or place of purchase for a refund and contact Baxter Healthcare Corporation for further instructions regarding the return process.
For additional questions or to report a problem, 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

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules

Model:

NDC 36000-092-10

Recall #: D-0076-2021

Lot Numbers:

A0B1241 (Exp 10/2020)

A0C0091 (Exp 12/2020)

A0D0268 (Exp 02/2022)

Date Ranges: Expiration 10/2020, Expiration 12/2020, Expiration 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86529

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Pharmacies; Healthcare Providers

Manufactured In: United States, India

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 medication supply for Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) in 10 x 2 mL single-dose ampules with NDC 36000-092-10.

Specifically look for the following affected lot numbers and expiration dates: Lot A0B1241 (Exp 10/2020), Lot A0C0091 (Exp 12/2020), and Lot A0D0268 (Exp 02/2022).

If you have an affected product, stop using it immediately and quarantine the units to prevent accidental use.

Contact your healthcare provider or pharmacist immediately for guidance if you have been administered this product or if you have it in your possession.

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

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