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American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vi

Posted Mar 16 2011 6:03pm
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:
Professional Service Department
1-877-788-3232

American Regent Inc.
PV@luitpold.com
Phone: 1-800-734-9236
Fax: (610) 650-7781
or (610) 650-0170

FOR IMMEDIATE RELEASE - March 15, 2011 - American Regent is conducting a voluntary nationwide recall of the following products:

Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial NDC # 0517-2930-25
 
and
 
Concentrated Sodium Chloride Injection, USP, 23.4%, 100 mL Pharmacy Bulk Package NDC # 0517-2900-25

PLEASE NOTE: This voluntary nationwide recall, initiated on March 15, 2011 to the User Level, is for Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages. See attached APPENDIX for ALL the lots subject to this recall.

This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. 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. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.

Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Concentrated Sodium Chloride Injection, USP, 23.4% with the lot #s on the attached Appendix for patient care and should immediately quarantine any product for return.

American Regent has identified the source of the particulates and has taken the necessary steps to correct this issue. The company is initiating this voluntary recall for these lots manufactured prior to the implementation of this corrective action. 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 Concentrated Sodium Chloride 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 questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, emergency rooms, infusion centers, clinics and 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.

Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial NDC # 0517-2930-25

Lot#
Expiration Date First Distribution Date
9198 03/31/2011 04/21/2009
9252 04/30/2011 05/21/2009
9299 04/30/2011 06/01/2009
9305 05/31/2011 06/23/2009
9402 06/30/2011 07/13/2009
9423 06/30/2011 07/30/2009
9432 06/30/2011 08/20/2009
9553 08/31/2011 09/11/2009
9595 08/31/2011 10/05/2009
9646 09/30/2011 10/28/2009
9681 10/31/2011 11/23/2009
9737 10/31/2011 12/21/2009
9797 11/30/2011 01/11/2010
9831 12/31/2011 02/08/2010
0051 01/31/2012 03/02/2010
0095 02/28/2012 03/17/2010
Concentrated Sodium Chloride Injection, USP, 23.4%, 100 mL Pharmacy Bulk Package NDC # 0517-2900-25

Lot # Expiration Date First Distribution Date
9225 04/30/2011 05/06/2009
9492 07/31/2011 08/07/2009
9711 10/31/2011 11/03/2009
0007 01/31/2012 01/26/2010
0058 01/31/2012 03/02/2010

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

    
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