VistaPharm LLC has voluntarily recalled four lots of Aminocaproic Acid Oral Solution (0.25 grams/mL), a prescription medication used to treat certain bleeding disorders. The recall was initiated because the product was found to contain high levels of ethylene glycol, an impurity that exceeds safe limit specifications. Approximately 2,352 bottles were distributed nationwide in 8 Fl. Oz. plastic containers. To date, there have been no reports of incidents or injuries related to this recall.
Ethylene glycol is a toxic substance; consuming high levels can lead to serious health complications including kidney failure, metabolic acidosis, and nervous system damage.
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Manufactured for VistaPharm, Inc. in Largo, FL.
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Sources: FDA iRES · Raw API Response
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