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

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 Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial

NDC # 0517-0639-25

and

Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL, Single Dose Vial

NDC # 0517-1550-25

PLEASE 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. via email at [email protected], by fax to 610-650-7781 or 610-650-0170 or by phone at 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.

APPENDIX

American Regent Recall Lots of Sodium Bicarbonate Injection, USP

Sodium Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial

NDC # 0517-0639-25

Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Single Dose Vial

NDC # 0517-1550-25

SOURCE Luitpold Pharmaceuticals, Inc.

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