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

Mar 16, 2011, 17:32 ET from Luitpold Pharmaceuticals, Inc.

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 Vials

                                                                                                NDC # 0517-4901-25;

                                                                                                             and

                                           Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 5 mL Multiple Dose Vials

                                                                                                NDC # 0517-4905-25;

                                                                                                             and

                                          Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vials

                                                                                                NDC # 0517-4930-25



PLEASE 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.


Dexamethasone Sodium Phosphate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).



APPENDIX


American Regent Recall Lots of

Dexamethasone Sodium Phosphate Injection, USP


Dexamethasone Sodium Phosphate Injection, USP

4 mg/mL, 1 mL Single Dose Vial


NDC # 0517-4901-25



Lot Number

Expiration Date

First Distribution Date

9153

03/2011

04/07/2009

9170

03/2011

04/15/2009

9182

03/2011

04/28/2009

9218

03/2011

05/06/2009

9254

04/2011

05/18/2009

9295

04/2011

05/27/2009

9329

05/2011

06/08/2009

9352

05/2011

06/18/2009

9368

05/2011

06/30/2009

9385

06/2011

07/14/2009

9422

06/2011

07/24/2009

9425

06/2011

08/04/2009

9441

06/2011

08/14/2009

9512

07/2011

08/25/2009

9549

08/2011

09/08/2009

9565

08/2011

09/21/2009

9605

09/2011

09/30/2009

9615

09/2011

10/14/2009

9615A

09/2011

10/20/2009

9656

09/2011

10/26/2009

9668

09/2011

11/06/2009

9690

10/2011

11/18/2009

9710

10/2011

12/01/2009

9722

10/2011

12/14/2009

9743

10/2011

12/23/2009

0135

03/2011

04/01/2010

0138

03/2011

04/12/2010

0164

03/2011

04/13/2010

0215

03/2011

04/22/2010

0229

04/2011

04/26/2010

0245

04/2011

05/05/2010

0271

04/2011

05/19/2010

0277

04/2011

06/01/2010

0282

04/2011

06/16/2010

0296

04/2011

06/30/2010

0302

05/2011

07/15/2010

0305

05/2011

07/28/2010

0324

05/2011

08/12/2010

0331

05/2011

08/24/2010

0342

05/2011

09/07/2010

0409

06/2011

09/21/2010

0444

06/2011

10/04/2010

0593

09/2011

10/13/2010

0599

09/2011

10/26/2010

0639

09/2011

11/08/2010

0678

10/2011

11/15/2010

0710

10/2011

11/23/2010

0736

10/2011

12/08/2010

0773

11/2011

12/21/2010

0792

11/2011

12/21/2010

0803

11/2011

12/28/2010

0819

11/2011

01/03/2011

0836

12/2011

01/25/2011

0846

12/2011

02/10/2011

0853

12/2011

02/23/2011

0879

12/2011

03/11/2011




APPENDIX


American Regent Recall Lots of

Dexamethasone Sodium Phosphate Injection, USP



Dexamethasone Sodium Phosphate Injection, USP

4 mg/mL, 5 mL Multiple Dose Vial


NDC # 0517-4905-25


Lot Number

Expiration Date

First Distribution Date

9210

03/2011

04/16/2009

9250

04/2011

05/18/2009

9335

05/2011

06/11/2009

9393

05/2011

07/06/2009

9417

06/2011

08/03/2009

9516

08/2011

09/02/2009

9571

08/2011

09/29/2009

9620

09/2011

10/21/2009

9667

09/2011

11/18/2009

0157

03/2011

04/01/2010

0217

03/2011

04/27/2010

0269

04/2011

05/20/2010

0317

05/2011

06/16/2010

0392

06/2011

07/14/2010

0404

06/2011

08/10/2010

0407

06/2011

09/01/2010

0556

08/2011

09/30/2010

0624

09/2011

10/26/2010

0704

10/2011

11/22/2010

0765

11/2011

12/20/2010

0805

11/2011

12/23/2010

0878

12/2011

01/18/2011

1055

01/2012

02/22/2011




Dexamethasone Sodium Phosphate Injection, USP

4 mg/mL, 30 mL Multiple Dose Vial


NDC # 0517-4930-25


Lot Number

Expiration Date

First Distribution Date

0213

03/2011

05/04/2010

0306

05/2011

06/23/2010

0387

06/2011

08/02/2010

0565

08/2011

09/22/2010

0679

10/2011

11/03/2010

0771

11/2011

12/22/2010

0840

12/2011

01/14/2011




 

SOURCE Luitpold Pharmaceuticals, Inc.



RELATED LINKS

http://www.americanregent.com