FDAClass IIFebruary 10, 2016

Nystatin recall: Labeling Error

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

Why was Nystatin recalled?

Labeling: label error on declared strength.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 2015050194, Exp 2/2016

Product
Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
Recalling firm
Perrigo Company PLC
Quantity
948 units
Distribution
Nationwide
Recall date
February 10, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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