Mislabeling of Quadruple-Dose Fentanyl Patches Prompts Recall

The U.S. Food and Drug Administration has announced a recall of 50 microgram per hour fentanyl patches that were mislabeled as 12 microgram patches. “Application of a 50 microgram per hour patch instead of a prescribed 12 microgram per hour patch could result in serious, life threatening or fatal respiratory depression,” the FDA said in a statement. “Groups at potential increased risk could include first-time recipients of such patches, children and the elderly.” Alvogen Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 microgram ...