VistaPharm, Inc. has recalled approximately 4,065,550 units of NYSTATIN Oral Suspension, USP 500,000 Units/5mL, because the medication failed quality tests for impurities and degradation levels. NYSTATIN is a prescription antifungal medicine, and if it contains impurities above approved levels, it may not work effectively or could cause unexpected side effects. The affected products consist of 5ml unit dose cups sold in packs of 50 or 100 and were distributed nationwide across the United States and Puerto Rico. Consumers with the affected medication should contact their pharmacist or healthcare provider for instructions on how to handle the recall.
The drug contains impurities that exceed approved specifications, which means the chemical composition of the medicine has changed. This degradation can lead to the medication being less effective at treating infections or potentially causing adverse health reactions due to the breakdown of the active ingredients.
Pharmacy refund
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Sources: FDA iRES · Raw API Response
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