Exela Pharma Sciences LLC is recalling one lot of Sodium Bicarbonate Injection, USP (4.2%), which is a medication used to treat metabolic acidosis or certain drug toxicities. The recall was initiated because testing detected levels of arsenic that exceed the allowable safety specifications. This product is a sterile injectable liquid distributed in 10 mL single-dose glass vials to hospitals and healthcare facilities nationwide.
The product contains arsenic levels higher than permitted, which poses a risk of heavy metal toxicity. While this is a sterile injectable used in clinical settings, the manufacturer has identified it as a medium-level risk due to the potential for systemic harm from the impurity.
Recall #: D-0620-2025; Manufactured and Distributed by Exela Pharma Sciences, LLC
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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