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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 facilities should not use American Regent Inc., Dexamethasone Sodium Phosphate Injection, USP 4mg/mL, 1mL Single Dose Vials, 5mL and 30 mL  Multiple Dose Vials with the lot #s listed in the attached Appendix for patient care and should immediately quarantine any product for return.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary nationwide recall.  American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Dexamethasone Sodium Phosphate Injection, USP Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."

American Regent will credit accounts for all returned product with these lot #'s. Those with product to return may do so by accessing our recall website at www.americanregent.com/recall/adx.   If you have questions about the return or recall process, please contact our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET or by email at recall@americanregent.com.Hospitals, emergency rooms, infusion centers, clinics, physician offices and other healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.Any adverse reactions experienced with the use of this product 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.  TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178

  • Dexamethasone Sodium Phosphate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).APPENDIXAmerican Regent Recall Lots ofDexamethasone Sodium Phosphate Injection, USPDexamethasone Sodium Phosphate Injection, USP4 mg/mL, 1 mL Single Dose VialNDC # 0517-4901-25Lot NumberExpiration DateFirst Distribution Date9153

    03/2011

    04/07/20099170

    03/2011

    04/15/20099182

    03/2011

    04/28/20099218

    03/2011

    05/06/20099254

    04/2011

    05/18/20099295

    04/2011

    05/27/20099329

    05/2011

    06/08/20099352

    05/2011

    06/18/20099368

    05/2011

    06/30/20099385

    06/2011

    07/14/20099422

    06/2011

    07/24/20099425

    06/2011

    08/04/20099441

    06/2011

    08/14/20099512

    07/2011

    08/25/20099549

    08/2011

    09/08/20099565

    08/2011

    09/21/20099605

    09/2011

    09/30/20099615

    09/2011

    10/14/20099615A

    09/2011

    10/20/20099656

    09/2011

    10/26/20099668

    09/2011

    11/06/20099690

    10/2011

    11/18/20099710

    10/2011

    12/01/20099722

    10/2011

    12/14/20099743

    10/2011

    12/23/20090135

    03/2011

    04/01/20100138

    03/2011

    04/12/20100164

    03/2011

    04/13/20100215

    03/2011

    04/22/20100229

    04/2011

    04/26/20100245

    04/2011

    05/05/20100271

    04/2011

    05/19/20100277

    04/2011

    06/01/20100282

    04/2011

    06/16/20100296

    04/2011

    06/30/20100302

    05/2011

    07/15/20100305

    05/2011

    07/28/20100324

    05/2011

    08/12/20100331

    05/2011

    08/24/20100342

    05/2011

    09/07/20100409

    06/2011

    09/21/20100444

    06/2011

    10/04/20100593

    09/2011

    10/13/20100599

    09/2011

    10/26/20100639

    09/2011

    11/08/20100678

    10/2011

    11/15/20100710

    10/2011

    11/23/20100736

    10/2011

    12/08/20100773

    11/2011

    12/21/20100792

    11/2011

    12/21/20100803

    11/2011

    12/28/20100819

    11/2011

    01/03/20110836

    12/2011

    01/25/20110846

    12/2011

    02/10/20110853

    12/2011

    02/23/20110879

    12/2011

    03/11/2011APPENDIXAmerican Regent Recall Lots ofDexamethasone Sodium Phosphate Injection, USPDexamethasone Sodium Phosphate Injection, USP4 mg/mL, 5 mL Multiple Dose VialNDC # 0517-4905-25Lot NumberExpiration DateFirst Distribution Date9210

    03/2011

    04/16/20099250

    04/2011

    05/18/20099335

    05/2011

    06/11/20099393

    05/2011

    07/06/20099417

    06/2011

    08/03/20099516

    08/2011

    09/02/20099571

    08/2011

    09/29/20099620

    09/2011

    10/21/20099667

    09/2011

    11/18/20090157

    03/2011

    04/01/20100217

    03/2011

    04/27/20100269

    04/2011

    05/20/20100317

    05/2011

    06/16/20100392

    06/2011

    07/14/20100404

    06/2011

    08/10/20100407

    06/2011

    09/01/20100556

    08/2011

    09/30/20100624

    09/2011

    10/26/20100704

    10/2011

    11/22/20100765

    11/2011

    12/20/20100805

    11/2011

    12/23/20100878

    12/2011

    01/18/20111055

    01/2012

    02/22/2011Dexamethasone Sodium Phosphate Injection, USP4 mg/mL, 30 mL Multiple Dose VialNDC # 0517-4930-25Lot NumberExpiration DateFirst Distribution Date0213

    03/2011

    05/04/20100306

    05/2011

    06/23/20100387

    06/2011

    08/02/20100565

    08/2011

    09/22/20100679

    10/2011

    11/03/20100771

    11/2011

    12/22/20100840

    12/2011

    01/14/2011 


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    SOURCE Luitpold Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
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