NEW YORK - Johnson & Johnson said today that its PriCara division recalled two lots of the pain patch Duragesic, or fentanyl, because of tears in the products that could expose users directly to the product's effective gel, causing an overdose.
In February, the New Brunswick, N.J.-based company issued a similar recall, but on a larger scale for a less potent dosage of the drug. In a statement, the company said the latest manufacturing problems have been corrected.
Duragesic, or fentanyl, is a potent opioid pain reliever, and skin exposure directly to the gel within the patch can lead to respiratory problems and a fatal overdose. Alza Corp., an affiliate of PriCara based in Mountain View, Calif., manufactured the patches being recalled.
The company said Duragesic 50 mcg/hr patches under the lot number 0817239 are being recalled. Anyone with that product should call 800-547-6446. Also, Sandoz Inc. 50 mcg/hr patches under the lot number 0816851 are being recalled. People with products containing that lot number should call 800-901-7236.
PriCara urged anyone who comes in contact with fentanyl gel to thoroughly wash exposed skin with water only as anything else may only increase the medicine's ability to go through the skin. Patches with cut edges should be carefully disposed of by flushing them down the toilet, without directly handling them.
The latest problem is smaller than a February recall when all lots of 25 mcg/hr patches, a less potent dose, were recalled. Those products had similar defects and were also manufactured by Alza.
PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of consumer and health care products company Johnson & Johnson. J&J has other operations in the Philadelphia region.
The recall is being conducted in conjunction with the Food and Drug Administration. Other strengths including 12.5, 25, 75 and 100 mcg/hr are not affected, the company added.