product recall

[Guest guest]

Subject:

URGENT PRODUCT RECALL regarding Fentanyl Patches--DURAGESIC® from Cheryl in CA

URGENT PRODUCT RECALL

regarding Fentanyl Patches http://www.duragesic.com/potential/recall.jsp

DURAGESIC® (fentanyl transdermal system) complete U.S. prescribing

information URGENT PRODUCT

RECALL JANSSEN PHARMACEUTICA ANNOUNCES RECALL OF ONE LOT (CONTROL NUMBER

0327192)

OF 75 MCG/HOUR DURAGESIC®

(FENTANYL TRANSDERMAL SYSTEM CII) PATCHES TITUSVILLE, NJ, February 16, 2004 -

Janssen Pharmaceutica Products, L.P., is

recalling one manufacturing

lot (control number 0327192) of the 75 mcg per hour strength of its

prescription DURAGESIC® (fentanyl transdermal system

CII) patches, which are used

to treat moderate to severe chronic pain. A small percentage of these patches,

which were distributed only in the U.S., may leak medication along one

edge. No other lots or dosage strengths are affected. The company has consulted

with the U.S. Food and Drug

Administration. (For more

detailed information, see www.Duragesic.com.)

If the medication leaks from the patch, patients can get either too much or

too little medication.

Exposure to too much medication can occur if the medicine leaks directly onto

the skin and the body absorbs a higher than intended amount. This overexposure

may cause nausea, sedation, drowsiness, or potentially life-threatening

complications. If the medication leaks out, there may not be enough to provide

adequate pain control and the patient may experience withdrawal symptoms. These

include sweating, sleeplessness, and

abdominal discomfort.

Healthcare professionals, caregivers, or anyone who comes in contact with an

affected patch from this lot

(DURAGESIC 75 mcg per hour, control number

0327192) also may be at

risk. Anyone who comes in contact with the leaked medication should thoroughly

rinse exposed skin with water only; do not use

soap. Anyone who has 75

mcg per hour DURAGESIC patches should check the outer

carton or foil pouch for the

control number 0327192. Those who have patches from the affected lot must

contact their physician or pharmacist immediately for specific instructions and

to coordinate returning affected patches and obtaining a new supply. Patients

wearing DURAGESIC patches that are not from the affected lot can continue to

wear them with confidence. Sudden

discontinuation of DURAGESIC

can cause health problems. DURAGESIC is a prescription transdermal opioid

medication indicated for the

treatment of moderate to

severe chronic pain. DURAGESIC patches are available in four dosage strengths -

25 mcg per hour, 50 mcg per hour, 75 mcg per hour and 100 mcg per hour. This

voluntary recall affects one lot (control number 0327192) of the 75 mcg per

hour dosage strength. No other lots of the 75 mcg per hour dosage strength are

affected. No other dosage

strengths are affected.

The company estimates that significantly fewer than 19,000 patches, or less

than five percent of this

lot, are affected by this problem. This quantity represents much less than one

percent of the total DURAGESIC patches that are currently in distribution. The

affected lot was shipped to distributors

in the United States between mid-December

2003 and early January 2004. Janssen Pharmaceutica is committed to the

integrity of its products and the health and safety of the patients who use its

products. For information on this product recall, please visit www.Duragesic.com or www.Janssen.com.

The Web sites contain written material and photos of the pouch illustrating the

control number. For those without Internet access or to report an adverse

event, please call 1-800-JANSSEN (1-).