• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

  • Print
  • Share
  • E-mail

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
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #: Patch 453658; Carton 453658A, Exp 09/13 Class III Failed Impurities/Degradation Specifications 98,952 boxes D-599-2013