A labeling problem has forced Teva to recall 13 lots of fentanyl buccal tablets. Safety updates on the product insert were omitted, leaving the possibility of misuse that “could lead to life-threatening adverse events,” the FDA said.
The likelihood of harm stemming from the error is “remote,” according to a hazard assessment conducted by Teva. The company has not yet received any complaints related to the product’s labeling, it said.
Teva manufactured and labeled the product for Mayne Pharma. The recall is to the consumer level.
The 13 lots are for a variety of strengths of the product, ranging from 100- to 800-microgram doses. Expiration dates of the lots range from June 2023 to November 2024. The tablets come in packages of 28, with four cards containing seven pills each.
Fentanyl buccal is an opioid agonist, indicated for the management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to around-the-clock opioid therapy.
The recall comes after a major transition for Mayne Pharma. In December, the company paid $153 million to license women’s healthcare products from TherapeuticsMD, which made the move after failing to sell itself.
Two months later, Mayne sold a chunk of its U.S. generics portfolio to Dr. Reddy’s Laboratories of India. That deal was for up to $105 million and included four pipeline and 40 approved but unmarketed drugs.