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
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.
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 |
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 |
###