Wednesday, PriCara, a unit of consumer and health care products company Johnson & Johnson (JNJ), said it has voluntarily recalled two lots of the pain patch Duragesic or fentanyl, citing possible tears in the reservoir containing the drug, which may cause an overdose. The fifth recall since 1994 is being conducted in conjunction with the U.S. Food and Drug Administration.
Duragesic CII patch medication provides long-lasting relief from persistent moderate-to-severe chronic pain. Through its innovative patch technology, Duragesic delivers fentanyl, an opioid pain medication, into the body slowly through the skin, where it works to relieve pain for up to 3 days.
As per the approved product labeling, direct exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.
PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., said that Duragesic 50 mcg/hr patches under the lot number 0817239 are being recalled. Sandoz Inc. 50 mcg/hr patches under the lot number 0816851 are also being recalled. PriCara noted that its affiliate Alza Corp. of Mountain View, California manufactured the patches being recalled. The company expects six defective patches in the two lots of 410,000 patches. Other strengths including 12.5, 25, 75 and 100 mcg/hr were not affected, the company added.
PriCara urged anyone who comes in contact with fentanyl gel to thoroughly wash exposed skin with water only. The company also suggested disposing the patches with cut edges by flushing them down the toilet, without directly handling them.
A similar recall was issued in the month of February but on a larger scale for a less potent dosage of the drug. Alza gets the notorious distinction of being the manufacturer for those defective products as well. In a statement, the company said the latest manufacturing problems have been corrected.
Johnson & Johnson is currently trading at $59.47, up $0.30 or 0.51% on the NYSE.
by RTT Staff Writer
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