Teva Pharmaceuticals is recalling certain lots of Fentanyl Buccal Tablets CII because safety updates were omitted in the product insert/medication guide provided with the recalled lots.
Fentanyl buccal tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain.
Not having the complete information to make informed decisions regarding the safe use of the product could potentially result in life-threatening adverse events. At this time, there have been no complaints related to the product labeling. A Health Hazard Assessment conducted by Teva showed that harm due to this labeling error was unlikely to occur.
The list of recalled products is available here. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label.
Teva initiates voluntary nationwide recall of specific lots of Fentanyl Buccal Tablets CII due to a labeling error. News release. Food and Drug Administration. April 28, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling.