Teva Pharmaceuticals USA is recalling specific lots of various strengths of Fentanyl Buccal Tablets. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide that are provided with these recalled lots.
The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. Not following, or not being aware of, the omitted safety updates in the Product Insert/Medication Guide could lead to life-threatening adverse events; although, based on a Health Hazard Assessment conducted by Teva, the likelihood of the harm occurrence is considered remote.
To date, Teva has not received any complaints related to the product labeling.
Fentanyl buccal tablets are an opioid agonists 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.