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Recall Observatory FDA recall evidence

Drug product

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

D-0651-2016

January 18, 2016

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 73101
Status
Terminated
Classification
Class II
Quantity
948 units
Official record key
drug-enforcement:D-0651-2016

Official wording

Reason: Labeling: label error on declared strength.

Code information: Lot #: 2015050194, Exp 2/2016

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: label error