December 12, 2022

FDA: Exela Pharma Sciences, LLC, expands recall of Sodium Bicarb

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on November 29 posted Exela Pharma Sciences’ expansion of its recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton.

The product poses a safety concern because of vial breakage with flying glass when pressurized while preparing the product for administration.

The company added 14 more lots to its ongoing recall of 49 lots, which it announced on October 12.

The additional lots were distributed October 26, 2021, through April 25, 2022.

There have been no reports of personal injury across all 63 lots since the recall process started.


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