Akorn, Inc. is recalling 2,796 bottles of Nystatin Oral Suspension, USP (100,000 units per mL), an antifungal medication used to treat yeast infections in the mouth. This recall was initiated because the product failed quality testing after 18 months, showing the presence of an unknown impurity that exceeded safety specifications. Consumers who have this medication should contact their healthcare provider or pharmacist, as the presence of unexpected degradants could impact the drug's safety or effectiveness.
The medication contains an unknown impurity discovered during long-term stability testing, which means the chemical composition of the drug has changed over time. Using a medication with such impurities could lead to unpredictable side effects or a lack of effectiveness in treating the underlying infection.
Healthcare provider consultation and pharmacy refund
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Sources: FDA iRES · Raw API Response
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