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One lot of the Duragesic pain patch and one lot of the generic Sandoz fentanyl pain patch have been recalled due to a manufacturing defect that could allow gel to leak from the patches, posing a serious risk of fentanyl overdose or death if the gel comes into direct contact with the skin.
The fentanyl pain patch recall was announced last week by PriCara, a subsidiary of Johnson & Johnson, who indicates that Duragesic 50 mcg/hr patches from lot number 0817239 and Sandoz 50 mcg/hr patches from lot number 0816851 may have a cut along one side of the drug reservoir. This could allow fentanly gel to leak out of the patch into the pouch they are packaged in, posing a serious risk for patients and caregivers.
Both lots of the fentany pain patch were manufactured by Alza Corp., an affiliate of PriCara.
The pain patch, which was first approved in 1994 under the brand name Duragesic, is used for continuous relief from chronic pain. It contains the powerful opiid painkiller fentanyl, which is contained between sealed layers of the patch and slowly released in a controlled manner over a 72 hour period.
Some of the fentanyl pain patch products from these lots may have been improperly cut, potentially allowing the gel to come into direct contact with the skin. This could cause a fentanyl overdose, with potentially life-threatening respiratory depression or death.
A number of prior fentanyl pain patch recalls have been issued due to similar manufacturing problems that allowed drug to leak from the patch. In February 2008, 95 lots of 25 mcg/hr Duragesic pain patch products and generic Sandoz fentanyl patches were recalled because they were not properly cut.
Johnson & Johnson and their subsidiaries currently face over 60 fentanyl pain patch lawsuits involving their Duragesic product. The wrongful death lawsuits involve allegations that manufacturing defects caused users or caregivers to suffer an overdose or fentanyl death.
In the first four Duragesic pain patch lawsuits that have gone to trial, Johnson & Johnson’s subsidiaries were ordered to pay a total of over $35 million to the families of individual who died.