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U.S. Department of Health and Human Services

Enforcement Report - Week of February 10, 2016

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Product Detail

Product Description Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Recall Number D-0652-2016
Classification Class II
Code Info Lot #: 2015080484, Exp 02/2016
Product Distributed Qty 918 containers
Reason For Recall Labeling: label error on declared strength.

Event Detail

Event Id 73101
Product Type Drugs
Status Ongoing
Recalling Firm Perrigo Company PLC
City Allegan
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2016-01-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide