notyard
04-14-2009, 03:06 PM
FDA class II recall:
PRODUCT
DURAGESIC 50 mcg/h CII, (FENTANYL TRANSDERMAL SYSTEM), One (50 mcg/h) system, Rx only, NDC 50458-034-05; Fentanyl Transdermal System, 50 mcg/h, CII, One (50 mcg/h) System, Rx only, NDC 00781-7112-55, Recall # D-201-2009
CODE
Lot #: 0817239, exp 6/10 (Janssen); 0816851, exp 6/10 (Sandoz)
RECALLING FIRM/MANUFACTURER
GPSG – Unit of ALZA Corp., Vacaville, CA, by press release and letters on December 31, 2008. Firm initiated recall is ongoing.
REASON
Defective delivery system; due to a seal breach on one edge of the system, product has the potential to release higher or too little medication than intended amount.
VOLUME OF PRODUCT IN COMMERCE
411,690 patches
DISTRIBUTION
Nationwide
PRODUCT
DURAGESIC 50 mcg/h CII, (FENTANYL TRANSDERMAL SYSTEM), One (50 mcg/h) system, Rx only, NDC 50458-034-05; Fentanyl Transdermal System, 50 mcg/h, CII, One (50 mcg/h) System, Rx only, NDC 00781-7112-55, Recall # D-201-2009
CODE
Lot #: 0817239, exp 6/10 (Janssen); 0816851, exp 6/10 (Sandoz)
RECALLING FIRM/MANUFACTURER
GPSG – Unit of ALZA Corp., Vacaville, CA, by press release and letters on December 31, 2008. Firm initiated recall is ongoing.
REASON
Defective delivery system; due to a seal breach on one edge of the system, product has the potential to release higher or too little medication than intended amount.
VOLUME OF PRODUCT IN COMMERCE
411,690 patches
DISTRIBUTION
Nationwide