FDAnews Device Daily Bulletin

Watson Pharmaceuticals has adjusted calibration for a machine that manufactures its fentanyl transdermal patches after a small number of them that leaked prompted a voluntary recall of one lot of the product. The painkiller patches leaked because a machine used to cut the patches was cutting into the gel area, Watson spokeswoman Patty Eisenhaur said. “Now the calibration has been fixed so the operator can only calibrate the machine within a certain, tighter threshold,” she said.
Devices and Diagnostics Letter