Teva USA Recalls Fentanyl Buccal Tablets Manufactured and Labeled for Mayne Pharma Inc.

SIS Patient Safety Alert 05/01/2023: Specific Lots of Fentanyl Buccal Tablets Recalled by Teva Due to a Labeling Error

This is an important alert from the International Pain and Spine Intervention Society. IPSIS issues Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the U.S. Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

ISSUE: Teva Pharmaceuticals USA is recalling specific lots of various strengths of Fentanyl Buccal Tablets. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide that are provided with these recalled lots.

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 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.

To date, Teva has not received any complaints related to the product labeling.

Click here for more information about this recall.

BACKGROUND: Fentanyl buccal tablets are an opioid agonists 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.

RECOMMENDATIONS:

• Patients with questions or concerns should first consult with their health care provider(s).
• Instructions for returning recalled product and receiving a credit are given in the Recall letter and Consumer Recall letter released by the company.health care professional, because this could worsen the pain and increase the risk of respiratory depression.

Adverse reactions or side effects related to the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online; or
• Download the form, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178
  

Source: Food and Drug Administration - Accessed 05/01/2023

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