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If the solution becomes unexpectedly cloudy, develops discoloration, or contains foreign particulate matter that does not dissolve, the material should not be used for laboratory experiments until the cause has been determined

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Companies like Mylan (now part of Viatris), Teva, and Sun Pharmaceuticals have built entire patent litigation departments specifically to file Paragraph IV challenges at the earliest possible date

One significant concern is the increased risk of developing gallstones (cholelithiasis)