News

The FDA recently advised that rare but serious injuries, including death, have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake.

Sagent Pharmaceuticals, Inc. announced a nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) – an NSAID – due to a lack of sterility assurance.

Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches. Cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression.

The FDA is reminding healthcare professionals that sudden discontinuation of opioid pain medications for patients who are physically dependent can be harmful, resulting in withdrawal symptoms, uncontrolled pain, psychological distress, patients seeking other drugs, and suicide.