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Recall of Painkiller Patch Widened

Apr 8, 2004 |

Janssen Pharmaceutica has announced what the company called an "urgent" expansion of its recall of its painkiller patch Duragesic because of a leak that could cause life-threatening complications.

Janssen originally announced the recall of one batch in February, but now the recall has widened to four more batches.

The transdermal patches contain the opioid fentanyl in gel form. The company discovered that a seal along one edge allowed the drug to leak onto the skin. As a result, users could either be not getting enough, which can lead to withdrawal systems, or too much, which can lead to dangerous overdoses.

The recall applies to Duragesic patches releasing 75 micrograms per hour. The control numbers listed on the package are: 0327192, 0327193, 0327294, 0327295, and 0330362. Patients and caregivers who are exposed to the gel are urged to wash their hands with water only; soap should not be used.

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