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American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dos

Posted Mar 17 2011 11:26pm
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Contact:
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
631-924-4000
 

FOR IMMEDIATE RELEASE - March 16, 2011 - 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).
 

Source: Luitpold Pharmaceuticals, Inc.

 

APPENDIXAmerican 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

Expiration Date

First Distribution Date

Lot Number

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

 

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

NDC # 0517-4905-25

Expiration Date

First Distribution Date

9210
Lot Number

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

Expiration Date

First Distribution Date

0213
Lot Number

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
 

Recalled Product Photos Are Also Available on FDA's Flickr Photostream.

    
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