The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals USA voluntarily recalled specific lots of various strengths of fentanyl buccal tablets at the consumer level. Fentanyl buccal tablets (generic for Fentora^®) are an opioid analgesic used 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. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label.

Reason for medication recall

This recall was initiated because safety updates were omitted in the Product Insert/Medication Guide. The main safety concern is a potential for incomplete information needed by health care providers and consumers regarding safe use of the product. To date, Teva has not received any complaints related to the product labeling.

The following lots, distributed nationwide to pharmacies, are included in this recall:

Teva notified its customer, Mayne Pharma Inc., by letter to arrange for the return of all recalled products. Pharmacies should not dispense these products to consumers.

Impact on workers’ compensation and auto no-fault

There have been no transactions in the last six months in our book of business. If consumers do have recalled product, Teva recommends consulting with their pharmacy or prescriber. Some dispensing pharmacies may have already contacted consumers about this recall.

For more information on this recall and contact information for Teva, please click here.

If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.

Source:

1. U.S. Food and Drug Administration. Safety/Recalls, Market Withdrawals & Safety Alerts. Company Announcement: Teva Initiates Voluntary Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error | FDA accessed May 2, 2023.