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American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
Date:3/16/2011

SHIRLEY, N.Y., March 16, 2011 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall of the following:Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose VialsNDC # 0517-4901-25;andDexamethasone Sodium Phosphate Injection, 4 mg/mL, 5 mL Multiple Dose VialsNDC # 0517-4905-25;andDexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose VialsNDC # 0517-4930-25PLEASE NOTE:  This voluntary recall, initiated on March 16, 2011 to the User Level, is for ALL unexpired lots of all 3 sizes of Dexamethasone Sodium Phosphate Injection, USP.  See attached Appendix for Lot #s, Expiration Dates and Dates of First Distribution.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.  Potential adverse events after intravenous administration of solutions containing particulates, may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.  Intramuscular administration could result in foreign body inflammatory response, with local pain, swelling and possible long term granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues, if these lots of product are administered to patients.  

Dexamethasone Sodium Phosphate Injection, USP, is a synthetic adrenocortical steroid used to treat a variety of inflammatory and allergic conditions.  See the Full Prescribing Information at www.americanregent.com for a complete listing of indications and uses.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, emergency rooms, infusion centers, clinics, physician offices and other healthcare providers and
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SOURCE Luitpold Pharmaceuticals, Inc.
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