Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials Recalled Because Some Vials Contain Particulates

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Hospital Risk Managers, Pharmacy and Emergency Medicine healthcare personnel are informed by the FDA that Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials are recalled because some vials of these lots contain particulates and may cause adverse events including granuloma formation and damage to blood vessels in the lung.

Background of Sodium Bicarbonate Injection, USP

Sodium Bicarbonate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and distributed by American Regent, Inc. It is used for the treatment of metabolic acidosis and for the treatment of certain drug intoxications, including barbiturates in poisoning by salicylates or methyl alcohol and in hemolytic reactions. FDA Alert on Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials

FDA’s reason for the recall is that some vials of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose were found to contain particulates.

This can cause adverse events which include localized swelling and damage to blood vessels in the lung.

The affected products include all lots of:

• 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

Recommendation on Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials

“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 list in the firm press release for patient care and should immediately quarantine any product for return.”

Contacting the FDA to report cases with Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials

In case of detection of adverse events or side effects related to the use of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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