Johnson & Johnson Issued New Duragesic Pain Patch Recall in April

Johnson & Johnson issued a wholesale-level recall for its Duragesic Pain Patches in April.  According to the company, more than 53,000 Duragesic Pain Patches were recalled after at least one patch was found to have small crystals of the potent active ingredient.

Duragesic Pain Patches are fentanyl skin patches that are used to provide around-the-clock, long-lasting relief to patients with moderate-to-severe chronic pain who have developed a tolerance to narcotic painkillers.  The patches release fentanyl into the bloodstream through the skin, and can relieve pain for up to 72 hours. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

The  Duragesic Pain Patches were recalled by Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals unit. The recall involved  a single lot of Duragesic 25 microgram-per-hour patches, with an expiration date of March 2013, that were shipped to wholesalers between September and October 2011.  According to a notice posted on the U.S. Food & Drug Administration (FDA) website, Johnson & Johnson issued the Duragesic Pain Patch recall in April, after a patch exhibited white spots, which were determined to be small fentanyl crystals.  The recall was deemed Class III by the FDA, and Johnson & Johnson says no patient injuries have been linked to the recalled patches.

The FDA has issued several warnings regarding the risk of accidental overdose associated with fentanyl pain patches.  Just this past April, the agency warned that the devices posed dangers to children from accidental exposure to and improper storage and disposal of the fentanyl patch.  According to the FDA, there have been 26 cases of accidental exposure to fentanyl since 1997, most of them involving children younger than 2 years old. There have been 10 deaths and an additional 12 cases requiring hospitalization.

This is not the first time Johnson & Johnson has recalled Duragesic Pain Patches.  The company issued several such recalls between 2004 and 2008 because of defects that could cause the patches to leak fentanyl gel.  Johnson & Johnson has also been named in numerous lawsuits alleging the Duragesic patches caused dangerous overdoses.

Damaged fentanyl pain patches should never be used because the fentanyl could come in direct contact with the skin, leading to an accidental overdose.  Anyone exposed to fentanyl gel should seek medical attention if they experience:

•    Trouble breathing, or have slow or shallow breathing
•    Slow heartbeat
•    Severe sleepiness
•    Cold, clammy skin
•    Fainting, dizziness, confusion
•    Inability to think, walk, or talk normally
•    Seizure
•    Hallucinations