American Regent Recalls Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials Due to Particulate Matter

The following recall is being posted as some veterinarians may use this product in treating their patients.

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.

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.

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 PV@luitpold.com, 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: http://www.fda.gov/medwatch/report.htm

• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm Mail to address on the pre-addressed form.

• Fax: 1-800-FDA-0178

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