Teva Pharmaceuticals USA has voluntarily initiated a nationwide recall of certain lots of various strengths of FENTANYL Buccal Tablets CII. This move comes as a response to a labeling error that led to the omission of safety updates in the Product Insert/Medication Guide (MG) provided with these specific lots.
The recall, announced on April 27, 2023, involves products exclusively manufactured and labeled for Mayne Pharma Inc. under the Mayne brand by Teva USA. The primary safety concern revolves around the potential lack of complete information required for the safe use of the product by health care providers and patients.
Ignoring or being unaware of these omitted safety guidelines in the Product Insert/Medication Guide (MG) could potentially lead to serious, even life-threatening adverse events. However, Teva’s Health Hazard Assessment suggests the probability of such harm is remote. At this point, Teva has not received any complaints relating to the product labeling.
The specific products affected by the recall include various strengths of FENTANYL Buccal Tablets CII, identifiable by the provided NDC number and lot number, with expiration dates ranging from June 2023 to November 2024.
Fentanyl buccal tablets, an opioid agonist, are approved for managing breakthrough pain in cancer patients aged 18 and above. These patients should already be receiving and tolerant to round-the-clock opioid therapy for persistent cancer pain. Opioid tolerance is defined by specific dosages of various opioid medications taken consistently for a week or longer.
On April 27, 2023, Teva notified Mayne Pharma Inc., alerting them of the recall and requesting the return of the affected product. Instructions for returning the recalled product and obtaining credit have been provided in Teva’s recall letters.
Consumers with any questions or concerns are advised to consult their health care provider(s). In case of an adverse event or quality complaint, or for any medical-related questions, they can contact the numbers provided. Any adverse events or problems experienced with the use of this product can also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.
Teva has undertaken this recall with the knowledge of the Food and Drug Administration and will continue to liaise with and update all relevant stakeholders, including regulatory authorities, to address the issue. To aid identification of the recalled drug product, a description of the product’s carton labeling has been provided.
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