FDA Recalls B. Braun’s IV Solution

News: The Philippine Food and Drug Administration (FDA) has recalled 8.4% Sodium Bicarbonate Solution for intravenous (IV) infusion manufactured by German pharmaceutical company B. Braun Melsungen. The company recalled all products with the batch numbers 131558021, 124638022 and 121148021. The FDA said in an advisory that the recall is due to aluminium salt precipitation in the solution caused by fluctuation in the quality of bromobutyl stopper, which resulted in the leaching of aluminium compounds.

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Related sectors of this article: Pharmaceuticals & Healthcare, Regulatory - Pharmaceuticals & Healthcare
Geography: Philippines

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