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

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 [e-mail].

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 [e-mail], by fax to [phone] or [phone] 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).

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

First Distribution Lot Number Expiration Date 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

First Distribution Lot Number Expiration Date 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

First Distribution Lot Number Expiration Date 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 ---- ------- ----------

Luitpold Pharmaceuticals, Inc.

CONTACT: Walter Tozzi, R.Ph., M.S., M.B.A., Sr. Director of Professional
Services, [phone]

Web site: http://www.americanregent.com/