Fentanyl Recalls

Over the past 10 years, Fentanyl patch manufacturers under the FDA’s supervision have recalled millions of defective Fentanyl pain patches. Each time, the FDA ensured that public warnings were issued to notify health care providers and the public at large that using a defective Fentanyl pain patch could cause life-threatening consequences.

In February 2004, Janssen Pharmaceutica Products, LP issued a Class I Recall for one lot of the Duragesic Fentanyl transdermal pain patch. This recall was initiated because a potential seal breach on one edge of the patch (known as a “fold-over defect”) could allow a leak of Fentanyl gel. Janssen estimated that up to 19,000 of the Fentanyl patches in this recall might leak Fentanyl gel.

During the investigation into these recalled patches, the FDA found extensive manufacturing defects in addition to the “fold-over defects,” including the “stringer leaker” defect, “cut corners” in the patches, “bubbles in the seal” and holes in Fentanyl patches. Based upon this investigation, it is clear that millions of additional patches were manufactured in other batches that were not recalled but nonetheless potentially suffered from leak defects.

According to Janssen (a Johnson & Johnson subsidiary) during the February 2004 recall, exposure to the gel from a Duragesic Fentanyl patch “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.” In April 2004, Janssen expanded the February 2004 recall of defective Fentanyl patches to include more than one million additional Duragesic patches.

In February 2008, Johnson & Johnson was again forced to recall additional defective Duragesic Fentanyl patches. This time they recalled approximately 32 million patches due to possible leak defects. Included in this recall were millions of Fentanyl patches manufactured by Johnson & Johnson to be sold by Sandoz, Inc. as a generic of the Duragesic patch.

That same month, the international generic pharmaceutical company Actavis Group HF announced that millions of Actavis Fentanyl patches were being recalled from wholesalers and pharmacies because of concerns in the manufacturing process.

In March 2008, Actavis broadened its February 2008 recall to include all remaining lots of its transdermal Fentanyl patches. Also that month, the first recall of Watson Fentanyl patches occurred. According to the FDA, Watson Fentanyl patch Lot Number 92461681 was recalled because it was “super potent.”

In August 2008, a second Watson Fentanyl patch recall was announced in a press release by Watson Pharmaceuticals, Inc. In connection with this Fentanyl patch recall, Watson notified the U.S. Food and Drug Administration (FDA) that Fentanyl patches from Lot Number 92461850 were leaking Fentanyl gel, which could lead to potentially fatal respiratory depression and overdose for the patients using those patches.

In December 2008, additional Duragesic and Sandoz Fentanyl patches were recalled. Once again, a problem in the manufacturing process led to patches that may have a cut in the pouch exposing the patients directly to the dangerous Fentanyl gel. The companies cautioned that, if used, the defective patches could cause a fatal overdose.

In August 2009, Watson Pharmaceuticals, Inc. announced another recall of Watson Fentanyl patches — this time of all Fentanyl patches from Lot Number 145287A that were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. According to Watson’s press release, patches that leaked Fentanyl gel “have been detected in this lot, potentially exposing patients or caregivers directly to Fentanyl gel.” Watson Pharmaceuticals, Inc. further explained that “exposure to Fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.”

In October 2010, an additional recall of millions of Actavis Fentanyl patches was announced. The following month, an additional recall of Watson Fentanyl patches was announced for Lot Number 264085A. These Fentanyl patches were recalled by Watson because they suffered from a miscalibrated and/or defective delivery system.

If you or a loved one have been injured by a defective fentanyl patch, you may be eligible to file a lawsuit and receive compensation for your injuries. For a free legal consultation and to find out if you qualify for a fentanyl lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by filling out the free case evaluation form located on this page.