- Alvogen voluntarily nationwide recalled two lots of fentanyl transdermal system 12 mcg/h transdermal patches to the consumer level due to mislabeling on cartons labeled with 12 mcg/h containing 50 mcg/h patches that may results in life threatening or fatal respiratory depression
- The mislabeled products are manufactured by 3M Drug Delivery Systems. The mislabeled fentanyl transdermal patches lots include: Lot 180060, 12 mcg/h, expiry date May’20; Lot 180073, 12 mcg/h, expiry date Jun’20. The recall is being conducted under the knowledge of the US FDA
- The fentanyl transdermal patches are indicated for the management of pain in opioid tolerant patients. Fentanyl is also used as a recreational drug, often mixed with heroin or cocaine and has rapid effect which last< 2hrs.
Click here to read full press release/ article | Ref: Alvogen | Image: Alvogen