Azurity Pharmaceuticals, Inc. is recalling 2,220 bottles of Eprontia (topiramate) oral solution, 25 mg/mL, due to the presence of an impurity discovered during routine stability testing. The affected product is an outpatient prescription medication sold in 473 mL bottles. While no incidents or injuries have been reported, the medication exceeded established specifications for a specific degradation product.
The drug failed stability testing because it contained levels of Impurity C (4,5-desisopropylidene topiramate) that were higher than safety specifications allow. This degradation could potentially impact the effectiveness or safety of the medication for patients.
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Recall #: D-0213-2024; Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801
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Sources: FDA iRES · Raw API Response
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