Teva Pharmaceuticals is recalling specific lots of fentanyl tablets because safety updates were omitted in the product packaging.
Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label, according to the U.S. Food and Drug Administration.
This recall was initiated because safety updates were omitted in the product insert/medication guide that was provided with these recalled lots.
The main safety concern is the potential for not having complete information needed by healthcare providers and patients regarding the safe use of the product, the FDA said.
Click here to see the lot numbers and types of tablets being recalled.
Fentanyl buccal tablets are opioids used in 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, the company said.
Teva notified its customer, Mayne Pharma Inc. on April 27 that the lots were recalled and requested that they return the products impacted by the recall.
Consumers with questions or concerns should first consult with their healthcare provider.
You can contact the company by calling Quality Assurance Services at 888-838-2872, option 4.