D-599-2013 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2013
- Initiation Date
- June 3, 2013
- Termination Date
- April 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,952 boxes
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide
Code Information
Lot #: Patch 453658; Carton 453658A, Exp 09/13