Safety Report: Mayne Pharma Inc. FENTANYL Buccal Tablets CII - recalled due to Safety updates were omitted in the Product Insert, USA

United States

Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of specific lots of various strengths of FENTANYL Buccal Tablets CII to the Consumer Level. 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 (MG) 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 (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. To date, Teva has not received any complaints related to the product labeling.

The recalled products are:
NDC# Lot Exp. Date Strength Size
-51862-634-28 42617828 06/2023 100 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-634-28 100020465 01/2024 100 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-635-28 100020528 09/2024 200 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-635-28 100026699 11/2024 200 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-636-28 100020351 11/2024 400 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-636-28 100020522 09/2024 400 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-636-28 100026700 11/2024 400 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-637-28 42617831 06/2023 600 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-637-28 42619585 11/2023 600 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-637-28 100029649 11/2024 600 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-638-28 42617832 06/2023 800 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-638-28 42619530 08/2023 800 mcg 28 Buccal Tablets (4 tablets x 7 cards)
- 51862-638-28 100020532 11/2024 800 mcg 28 Buccal Tablets (4 tablets x 7 cards)

The approved product’s indications are: 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 considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.

Adverse events or other problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Teva Pharmaceuticals USA
Brand name: Mayne Pharma Inc.
Product recalled: FENTANYL Buccal Tablets CII
Reason of the recall: Safety updates were omitted in the Product Insert/Medication Guide (MG)
FDA Recall date: April 28, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling