Pharmaceutical Associates Inc. is recalling 275,400 cups of Nystatin Oral Suspension, USP (500,000 units/5 mL), a prescription medication used to treat fungal infections. The recall was initiated because the product failed to meet specifications for its appearance and its ability to mix properly when shaken (resuspension). This defect could result in a consumer receiving an inconsistent dose of the medication, which may lead to reduced effectiveness of the treatment.
If the medication does not resuspend properly, the active ingredient may settle at the bottom, causing the patient to receive too little of the drug in early doses and potentially too much in later doses. This inconsistency can prevent the infection from being treated effectively.
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Sources: FDA iRES · Raw API Response
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