If your email program has trouble displaying this email, view as a webpage.

TOPIC: Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection by Par Health: Recall - Due to the Presence of Particulate Matter

AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Pulmonology, Hematology

ISSUE: Par Health is recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper material.

Administration of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting.

To date, Par Health has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) is formulated for intravenous infusion. The product is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting and for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

RECOMMENDATIONS: 

• Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

• Questions regarding this recall can be directed to Inmar, Inc. at 1-833-599-3197 or by email at rxrecalls@inmar.com.

• For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download the form or call 1-800-332-1088 to request a reporting form, then complete it and return it to the address on the form or submit it by fax to 1-800-FDA-0178.

Follow us on X at @FDArecalls