Medications & Supplements/Prescription Drugs

Fresenius Kabi USA, LLC: Dexmedetomidine HCl Injection Recalled for Lidocaine Contamination

Agency Publication Date: December 8, 2020

Summary

Fresenius Kabi USA, LLC has recalled 13,525 bottles of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL). This prescription sedative, used in hospital settings, was found to contain trace amounts of lidocaine due to cross-contamination during manufacturing. Consumers and healthcare providers should be aware that this recall affects specific 50 mL single-dose bottles from lot 6123925.

Risk

The presence of trace amounts of lidocaine in a product not intended to contain it poses a risk of unintended drug exposure. This cross-contamination could lead to adverse reactions in patients sensitive to lidocaine or interfere with the intended sedative effects of the dexmedetomidine.

What You Should Do

Identify the affected product by checking the label for Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL) in a 50 mL Single Dose Bottle.
Check the bottle or packaging for NDC number 63323-671-05 and Lot number 6123925.
Immediately stop using any units belonging to the affected lot and quarantine them to prevent further use.
Contact your healthcare provider or pharmacist for guidance regarding any concerns about potential exposure or adverse effects.
Return any unused product from this lot to the pharmacy or place of purchase for a refund and contact Fresenius Kabi for further instructions.
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: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle

Model:

NDC 63323-671-05

Recall #: D-0120-2021

Lot Numbers:

6123925

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86766

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Sold By: Hospitals; Pharmacies

Manufactured In: United States

Units Affected: 13,525 bottles

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

Identify the affected product by checking the label for Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL) in a 50 mL Single Dose Bottle.

Check the bottle or packaging for NDC number 63323-671-05 and Lot number 6123925.

Immediately stop using any units belonging to the affected lot and quarantine them to prevent further use.

Contact your healthcare provider or pharmacist for guidance regarding any concerns about potential exposure or adverse effects.

Return any unused product from this lot to the pharmacy or place of purchase for a refund and contact Fresenius Kabi for further instructions.

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