Teva Pharmaceuticals USA is recalling specific lots of various strengths of FENTANYL Buccal Tablets CII<\/b> to the consumer level citing a labeling error, the U.S. Food and Drug Administration said.<\/p>\n
The recall has been initiated as safety updates were omitted in the product insert\/medication guide that are provided with these recalled lots.<\/p>\n
Fentanyl buccal tablet<\/b> is an opioid agonist 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. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet<\/b>.<\/p>\n
Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. The affected Buccal Tablets<\/b> come in a pack of 28, i.e., 4 tablets x 7 cards, with various strengths ranging from 100 mcg to 800 mcg, and various lot codes and expiry dates.<\/p>\n