D-1693-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2012
- Initiation Date
- July 11, 2012
- Termination Date
- April 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,088 cartons (5 pouches per carton)
Product Description
Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
Reason for Recall
Subpotent; some patches may not contain fentanyl gel
Distribution Pattern
Nationwide
Code Information
Lot number 455040A (carton) 455040 (pouch)