Teva recalls FENTANYL Buccal Tablets due to labeling error.
Teva Pharmaceuticals USA has issued a voluntary nationwide recall of specific lots of Fentanyl Buccal Tablets CII due to a labeling error that omitted safety updates in the Product Insert/Medication Guide. The recall was initiated exclusively for Mayne Pharma Inc. under Mayne’s label. The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. The likelihood of harm occurrence is considered remote, and to date, Teva has not received any complaints related to the product labeling.