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American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials Due to Particulate Matter
Date:12/23/2010

SHIRLEY, N.Y., Dec. 23, 2010 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the consumer and user level of ALL unexpired lots of the following products:

Sodium BicaronateInjection,USP, 7.5%, 44.6mEq/50mL, SingleDoseVialNDC# 0517-0639-25andSodium BicaronateInjection,USP, 8.4%, 50mEq50mL, SingleDose VialNDC# 0517-1550-25PLEASE NOTE:  This recall, initiated on December 23, 2010 to the User or Consumer Level is for ALL unexpired lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials.  See attached APPENDIX for ALL the lots subject to this voluntary recall.

This voluntary recall was initiated because some vials of these lots contain particulates.  Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and 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.

Sodium Bicarbonate Injection, USP, is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials with the lot #s on the attached list for patient care and should immediately quarantine any product for return.

"The safety of patients receiving our products is our primary concern. All of us at Luitpold Pharmaceuticals and American Regent are committed to taking the necessary steps to protect patients from any potential safety risks with our Sodium Bicarbonate Injection," said Mary Jane Helenek, President and CEO of American Regent.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary 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 Sodium Bicarbonate 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 is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product.  Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with these lot #'s. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, infusion centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 800-645-1706.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. viaemailaPV@luitpold.com, byfaxo 610-650-7781or 610-650-0170 orbyphoneat 1-800-734-9236.

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

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

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

APPENDIXAmerican Regent RecallLotsofSodiumicaronae Injection, USPSodium BicaronateInjection,USP, 7.5%, 44.6mEq/50mL, SingleDoseVialNDC# 0517-0639-25LoExpire Date8833

Dec-20109130

Feb-20119342

May-20119543

Aug-20119702

Oct-20110068

Feb-20120276

Apr-20120581

Aug-20120745

Nov-2012Sodium BicaronateInjection,USP, 8.4%, 50mEq50mL SingleDose VialNDC# 0517-1550-25LoExpire Date8845

Dec-20109062

Jan-20119058

Feb-20119111

Feb-20119128

Feb-20119158

Mar-20119180

Mar-20119212

Mar-20119262

Apr-20119271

Apr-20119292

Apr-20119346

May-20119346A

May-20119360

May-20119374

May-20119396

Jun-20119412

Jun-20119438

Jun-20119720

Oct-20119801

Nov-20119821

Nov-20110054

Jan-20120115

Feb-20120162

Mar-20120172

Mar-20120237

Apr-20120427

Jun-20120528

Aug-20120597

Sep-20120649

Sep-2012
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SOURCE Luitpold Pharmaceuticals, Inc.
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