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Vial Breakage Causes Nationwide Recall

A metabolic acidosis treatment packaged in glass vials is at risk of vial breakage and flying glass.

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A recent FDA announcement discussed the nationwide recall of sodium bicarbonate injections from Exela Pharma Sciences. The product poses a threat as the glass vial packaging is prone to breakage when pressurized during administration preparation. The company has received five reports of injury from flying glass, but no sterility issues. The affected lots are 50mL vials in 20-count cartons distributed to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022.

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