Drug & medication recalls Moderate risk

Perrigo Company PLC recalls Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05,…

Recall date
January 18, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0651-2016
FDA classification
Class II
Brand / firm
Perrigo Company PLC
Sold / distributed
Nationwide

Why it was recalled

Labeling: label error on declared strength.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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