American Regent Recalls Sodium Bicarbonate Injection

American Regent just initiated a nationwide recall of all unexpired lots of <"">Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials due to particulate matter, the U.S. Food and Drug Administration (FDA) just announced. Following are details for the products involved:

· 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

The FDA notes that 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. An appendix for all of the lots subject to this recall can be accessed at the FDA website at:

This 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. The product was distributed to wholesalers and distributors nationwide.

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.

Hospitals, infusion centers, clinics, and other healthcare facilities should not use the recalled American Regent Inc., Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials with the lot numbers indicated on the FDA appendix, and should immediately quarantine any product for return. 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 with the recalled products should stop its use. American Regent will credit accounts for all returned product with these lot numbers. Those with questions about the return process should contact the firm’s Customer Service Department, toll-free, at 1.800.645.1706, Monday through Friday, from 8:30 a.m. to 7:00 p.m., Eastern Time. Hospitals, infusion centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 1.800.645.1706.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at, by fax to 1.610.650.7781 or 1.610.650.0170, 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 via; regular mail, use postage-paid, pre-addressed Form FDA 3500 available at: and mail to address on the pre-addressed form; or by fax to 1.800.FDA-.0178

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

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