American Regent Recalls of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial

The following recall is being posted as some veterinarians may use this product in treating their patients.

American Regent is conducting a nationwide voluntary recall of the following: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 30 mL Multiple Dose Vial, NDC # 0517-4930-25.

PLEASE NOTE: This recall, initiated on December 20, 2010 to the User Level, is for these lots only. No other lots of the 30 mL MDV or other sizes of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, are subject to this recall.

This voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. American Regent is undertaking this recall in consideration of the potential for safety issues if these lots of product are administered to patients.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 30 mL Multiple Dose Vials with the above lot #’s for patient care and should immediately quarantine any product for return.

American Regent will credit accounts for all returned product with these lot #’s. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, infusion centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 800-645-1706.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA’s MedWatch Adverse Event Reporting program online⁹, or by returning the postage paid FDA form 3500¹⁰, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178] or phone 1-800-332-1088.