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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
Recall Number D-599-2013
Classification Class III
Code Info Lot #: Patch 453658; Carton 453658A, Exp 09/13
Product Distributed Qty 98,952 boxes
Reason For Recall Failed Impurities/Degradation Specifications

Event Detail

Event Id 65334
Product Type Drugs
Status Ongoing
Recalling Firm Actavis
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide