Recalled Duragesic Pain Patches

When the first Duragesic Transdermal Patches were recalled in February 2004, Janssen Pharmecutica believed that the problems were limited to a batch of certain products of a specific dosage. The recall was then expanded to other batch numbers of the 75 microgram per hour dosage from a certain manufacturer because the failure in the seal was discovered to affect more than one device.

Initially only Duragesic patches from lot Control #0327192 were recalled. The two halves of the device were connected by a faulty junction that allowed the drug fentanyl to seep out the sides. Unfortunately, lot #s 0327193, 0327294, 0327295 and 0330362 were also discovered to have this manufacturing defect. The final lots recalled as of July 2005 are:

Lot Control # 0327192

In February 2004, Janssen Pharmeceutica discovered a potentially catastrophic flaw in their extremely popular Duragesic Transdermal Patch. Reports revealed that the seal that held the two halves of the patch together were prone to leakage which caused the potent active ingredient fentanyl, an opiate 100 times more powerful than morphine, to come into direct contact with the skin.

When this flaw was discovered Janssen issued a recall of the 75 mcg/hour patches of lot control #0327192. Fentanyl is designed for extended relief of chronic pain; if too much is directly absorbed by the skin it can cause a fatal overdose. Conversely, if too much of the drug is lost before it is absorbed through the skin, patients who regularly use Duragesic patches may experience painful withdrawal symptoms.

Lot Control # 0327193

The second of the Duragesic Transdermal Patches to be recalled was lot control #0327193. It was initially believed that the flaw that affected only lot number #0327192 was unique to that specific group and dosage, but later on the recall was extended to include other batch numbers provided by a certain manufacturer in an effort to restrict the number of potentially fatal episodes.

The problem with the Duragesic patches stemmed from the nature of the seal between the two sides of the patch failed under certain circumstances which exposed the skin to concentrated fentanyl, a narcotic pain reliever 100 times more potent than morphine. This failure could potentially cause serious side effects, but on the other hand, if too much of the drug was lost patients often experienced painful withdrawal symptoms compounded by the loss of pain relief the patch was intended to deliver.

Lot Control # 0327294

In order to prevent a potentially fatal manufacturing defect from endangering the health and lives of millions of people, Janssen Pharmaceutica ordered a recall of 75 mcg/h Duragesic Transdermal Patches from lot control #0327294. These patches provided by one manufacture were speculated to suffer the same defect that initially prompted the recall, namely the faulty seal that allowed the active ingredient fentanyl to leak out.

If concentrated fentanyl comes into direct contact with the skin it could cause serious health complications. Conversely, leaky patches could cause too much of the drug to escape without delivering the necessary pain relief, compounding the initial chronic pain of the patient with equally unpleasant withdrawal symptoms.

Lot Control # 0327295

When Janssen Pharmaceutica recalled its Duragesic Transdermal Patch in February 2004, it was though that only certain groups of these devices were affected by a potentially fatal manufacturing defect. In April 2004 the company decided to recall five individual lot numbers rather than risk subjecting more people to potential risk. Janssen suspected lot control #0327295 possibly suffered the same leak in the seal that joined the two halves of the device together.

The failure of the seal between the two thin slivers of plastic cause a number of dangerous side effects. Fentanyl, the active painkilling agent in Duragesic, is much too powerful for use unless it is diffused in small amounts over an extended period of time. The faulty seals could potentially leak concentrated fentanyl directly onto the skin which can cause serious medical complications.

Lot Control # 0330362

When Janssen Pharmaceutica recalled its Duragesic Transdermal Patch in February 2004, it was though that only certain groups of these devices were affected by a potentially fatal manufacturing defect. In April 2004 the company decided to recall five individual lot numbers rather than risk subjecting more people to potential risk. Janssen suspected lot control #0330362 possibly suffered the same leak in the seal that joined the two halves of the device together.

Other Recalls

Not only did Janssen Pharmaceutica recall certain lot numbers of defective patches; leaks and similar problems have also been reported for other strength patches and other lot numbers. Duragesic isn't the only fentanyl patch affected. In fact, on July 15, 2005, the FDA issued a Public Health Advisory on all transdermal fentanyl patches, including the generic product manufactured by Mylan Laboratories. Please check back from time to time to find out more information.