Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.

FDA recall notice · announced February 10, 2016 · Perrigo

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.

Reason for recall

Labeling: label error on declared strength.

Notes

Distribution: Nationwide
Lot/code information: Lot #: 2015050194, Exp 2/2016
Quantity: 948 units
Status: Terminated
Products in this recall event:
- Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157 (D-0652-2016)
- Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058. (D-0651-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.