icnmgrjill
04-09-2004, 08:11 AM
April 7, 2004
URGENT EXPANDED DRUG RECALL NOTIFICATION - PATIENT LEVEL
Subject: DURAGESIC® (fentanyl transdermal system) CII 75 mcg/hour NDC #50458-035-05
Lot Control Numbers 0327192 (exp. 10/05) 0327193 (exp. 10/05),
0327294 (exp. 11/05), 0327295 (exp. 11/05), and 0330362 (exp. 12/05)
Dear Pharmacist:
Janssen Pharmaceutica Products, L.P. would like to inform you of an expanded recall to users of DURAGESIC (fentanyl transdermal system) CII 75 mcg/hour, NDC #50458- 035-05, control numbers 0327192 (exp. 10/05), 0327193 (exp. 10/05), 0327294 (exp. 11/05), 0327295 (exp. 11/05) and 0330362 (exp. 12/05).
The company recalled one lot of DURAGESIC 75 mcg/hour patches (control number 0327192) in February 2004 after determining that a small percentage of patches in this lot might leak medication along one edge. Since then, a small number of patches with the same problem have been identified in one additional lot.
As a precaution, the company is recalling four additional lots of 75 mcg/hour patches that were produced on the same manufacturing line during the same period. Exposure to the leaked medication could result in inadvertent ingestion or an increased transdermal absorption of the opiate component fentanyl, leading to potentially lifethreatening complications.
Conversely, leakage of medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.
Anyone who comes in contact with the leaked medication is advised to rinse exposed skin thoroughly with water only; soap should not be used.
For additional information - http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#duragesic
URGENT EXPANDED DRUG RECALL NOTIFICATION - PATIENT LEVEL
Subject: DURAGESIC® (fentanyl transdermal system) CII 75 mcg/hour NDC #50458-035-05
Lot Control Numbers 0327192 (exp. 10/05) 0327193 (exp. 10/05),
0327294 (exp. 11/05), 0327295 (exp. 11/05), and 0330362 (exp. 12/05)
Dear Pharmacist:
Janssen Pharmaceutica Products, L.P. would like to inform you of an expanded recall to users of DURAGESIC (fentanyl transdermal system) CII 75 mcg/hour, NDC #50458- 035-05, control numbers 0327192 (exp. 10/05), 0327193 (exp. 10/05), 0327294 (exp. 11/05), 0327295 (exp. 11/05) and 0330362 (exp. 12/05).
The company recalled one lot of DURAGESIC 75 mcg/hour patches (control number 0327192) in February 2004 after determining that a small percentage of patches in this lot might leak medication along one edge. Since then, a small number of patches with the same problem have been identified in one additional lot.
As a precaution, the company is recalling four additional lots of 75 mcg/hour patches that were produced on the same manufacturing line during the same period. Exposure to the leaked medication could result in inadvertent ingestion or an increased transdermal absorption of the opiate component fentanyl, leading to potentially lifethreatening complications.
Conversely, leakage of medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.
Anyone who comes in contact with the leaked medication is advised to rinse exposed skin thoroughly with water only; soap should not be used.
For additional information - http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#duragesic