Teva Recalls FENTANYL Buccal Tablets CII

Teva Recalls FENTANYL Buccal Tablets CII

May 5, 2023

Teva Pharmaceuticals USA is recalling specific lots of various strengths of FENTANYL Buccal Tablets CII to the consumer level citing a labeling error, the U.S. Food and Drug Administration said.

The recall has been initiated as safety updates were omitted in the product insert/medication guide that are provided with these recalled lots.

Fentanyl buccal tablet 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.

Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. The affected Buccal Tablets 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.

According to the agency, 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; although, based on a Health Hazard Assessment conducted by Teva, the likelihood of the harm occurrence is considered remote,” it said.

However, Parsippany, New Jersey -based Teva USA has not received any complaints related to the product labeling to date.

Teva notified Mayne Pharma on April 27, alerting them that the lots were recalled and requesting that they return impacted product.

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