Perrigo Voluntarily Recalls Two Lots of Nystatin Due to Labeling Error

Perrigo has issues a Class II voluntary recall for one lot (918 bottles) of nystatin, USP powder for prescription compounding, 150 million units, and one lot (948 containers) of nystatin, USP powder for prescription compounding, 50 million units due to a labeling error on the declared strength.

The recall was initiated on January 18, 2016 in the United States, according to the US Food and Drug Administration’s (FDA) Weekly Enforcement Report of February 10, 2016.

A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Nystatin is an antifungal.

Source: FDA (918 bottles) and FDA (948 bottles)

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