Medications & Supplements/Prescription Drugs

Fresenius Kabi USA, LLC: Sensorcaine-MPF Injection Recalled for Subpotency of Epinephrine

Agency Publication Date: December 22, 2020

Summary

Fresenius Kabi USA is recalling 4,411 trays of Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL. The recall was initiated because the epinephrine component of the medication was found to be subpotent during testing, meaning it may not provide the full intended dose. Consumers who have this medication should contact their healthcare provider or pharmacist, as the effectiveness of the treatment could be compromised.

Risk

A subpotent epinephrine component may lead to inadequate therapeutic effects during medical procedures, such as insufficient heart rate support or inadequate blood vessel constriction when needed.

What You Should Do

Check your medical supplies for Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL) in 30 mL Single Dose Vials.
Verify the batch number and expiration date on the vial or tray: look for Batch # 6123760 with an expiration date of 02/2022.
Confirm the National Drug Code (NDC) matches: NDC 63323-462-01 for single vials or NDC 63323-462-37 for trays of 25 vials.
Contact your healthcare provider or pharmacist immediately for guidance if you possess this affected medication.
Return any unused product to your pharmacy or place of purchase for a refund and contact Fresenius Kabi USA for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare 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: Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial

Model:

NDC 63323-462-01

NDC 63323-462-37

Lot Numbers:

6123760 (Exp 02/2022)

Date Ranges: Expiration 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86964

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Sold By: hospitals; clinics; pharmacies

Manufactured In: United States

Units Affected: 4411 trays

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 Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL) in 30 mL Single Dose Vials.

Verify the batch number and expiration date on the vial or tray: look for Batch # 6123760 with an expiration date of 02/2022.

Confirm the National Drug Code (NDC) matches: NDC 63323-462-01 for single vials or NDC 63323-462-37 for trays of 25 vials.

Contact your healthcare provider or pharmacist immediately for guidance if you possess this affected medication.

Return any unused product to your pharmacy or place of purchase for a refund and contact Fresenius Kabi USA for further instructions.

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