D-1693-2012 Class II Terminated

Recalled by Actavis — Salt Lake City, UT

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)