SODIUM BICARBONATE 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For recall — FDA D-0620-2025
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Overview of recall records associated with Exela Pharma Sciences LLC, including dates, categories and classifications where available.
Classification mix: Class II: 2.
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Lack of Assurance of Sterility
This page summarizes recall records in which the official source identifies Exela Pharma Sciences LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.