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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

alinization 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 th
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SOURCE Luitpold Pharmaceuticals, Inc.
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