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Class I Recall of Duragesic Initiated
February 23, 2004
Janssen Pharmaceutica and FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration
October 2005) is subject to this recall. A potential seal breach on one edge may allow drug to leak from the patch and could result in an increased
absorption of the opioid component, fentanyl, leading to increased drug
effect, including nausea, sedation, drowsiness, or potentially life
threatening complications. Conversely, if the hydrogel contents leak out of
the patch, there may not be adequate medication to treat the patients' pain.
In an opioid tolerant patient, this may lead to withdrawal symptoms, which include sweating, sleeplessness and abdominal discomfort.
Read the MedWatch 2004 safety summary, including links to the Recall Notice, Janssen Patient and Caregiver Information, and product photos, at: https://www.fda.gov/safety/safety-information/medwatch-safety-alerts-human-medical-products
Source: The FDA Safety Information and Adverse Event Reporting Program
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