notyard
08-22-2009, 01:09 PM
FDA class II recall:
PRODUCT
Fentanyl Transdermal System, 100 mcg/hr, Rx only, Packaged as 5 foil pouches per carton, 3214-54, Carton NDC 0591-3214-72, Recall # D-1891-2009
CODE
Lot # 145287A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Pharmaceuticals, Inc., Corona, CA, by letter on August 10, 2009. Manufacturer: Watson Pharmaceuticals, Salt Lake City, UT. Firm initiated recall is ongoing.
REASON
Possibility for leakage of Fentanyl gel from transdermal patches.
VOLUME OF PRODUCT IN COMMERCE
87,500 cartons
DISTRIBUTION
Nationwide
PRODUCT
Fentanyl Transdermal System, 100 mcg/hr, Rx only, Packaged as 5 foil pouches per carton, 3214-54, Carton NDC 0591-3214-72, Recall # D-1891-2009
CODE
Lot # 145287A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Pharmaceuticals, Inc., Corona, CA, by letter on August 10, 2009. Manufacturer: Watson Pharmaceuticals, Salt Lake City, UT. Firm initiated recall is ongoing.
REASON
Possibility for leakage of Fentanyl gel from transdermal patches.
VOLUME OF PRODUCT IN COMMERCE
87,500 cartons
DISTRIBUTION
Nationwide