Medications & Supplements/Prescription Drugs

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

Agency Publication Date: August 21, 2020

Summary

Fresenius Kabi USA is recalling approximately 25,100 bottles of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection (200 mcg per 50 mL). This medication, used for intravenous sedation, was found to contain trace amounts of lidocaine, a local anesthetic, due to cross-contamination during manufacturing. The recall affects 50 mL single-dose glass bottles distributed nationwide across the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed below and follow the return instructions provided.

Risk

The presence of trace amounts of lidocaine in a product intended for sedation poses a risk of unintended local anesthetic effects or allergic reactions in sensitive patients. While no injuries have been reported, cross-contamination with an undeclared drug can interfere with the primary treatment or cause adverse medical complications.

What You Should Do

Check your medical inventory or prescription for Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), 50 mL Single Dose Bottles (NDC 63323-671-05).
Identify if your product is from the affected lots: Lot 6121853 (Expiration 05/2021) or Lot 6122207 (Expiration 06/2021).
Stop using the affected product immediately and quarantine any remaining bottles to prevent further use.
Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to discuss potential alternatives.
Return any unused or remaining product to the pharmacy or place of purchase for a refund and contact Fresenius Kabi USA for specific return shipping instructions.
For further questions or to report adverse events, 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

Healthcare provider consultation and pharmacy 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 per 50 mL (4 mcg per mL), 50 mL Single Dose Bottle

Model:

NDC 63323-671-05

D-1537-2020

Lot Numbers:

6121853 (Exp 05/2021)

6122207 (Exp 06/2021)

Date Ranges: Expiration 05/2021, Expiration 06/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86095

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: United States

Units Affected: 25,100 bottles

Distributed To: Nationwide

Agency Last Updated: September 12, 2022

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 medical inventory or prescription for Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), 50 mL Single Dose Bottles (NDC 63323-671-05).

Identify if your product is from the affected lots: Lot 6121853 (Expiration 05/2021) or Lot 6122207 (Expiration 06/2021).

Stop using the affected product immediately and quarantine any remaining bottles to prevent further use.

Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to discuss potential alternatives.

Return any unused or remaining product to the pharmacy or place of purchase for a refund and contact Fresenius Kabi USA for specific return shipping instructions.

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