Teva Pharmaceuticals Recalls Specific Lots of Fentanyl Buccal Tablets CII
Teva Pharmaceuticals has voluntarily recalled specific lots of various strengths of fentanyl buccal tablets CII at the consumer level due to a labeling error. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide (MG) 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 (MG) could lead to life-threatening adverse events. Thirteen lots of this medication are affected by the recall.
