On April 27, 2023, the U.S. Food and Drug Administration (FDA) reported that Teva Pharmaceuticals USA, Inc., issued a voluntary recall of certain lots of fentanyl buccal tablets, a schedule II substance, to the consumer level because safety updates were omitted in the lots’ product insert/medication guide (MG). Teva Pharmaceuticals USA, Inc., manufactured and labeled the product lots exclusively for Mayne Pharma, Inc.
The main safety concern is the risk of healthcare providers and patients receiving incomplete information about safe use of the product, which could remotely lead to life-threatening adverse events, based on a health hazard assessment conducted by Teva Pharmaceuticals USA, Inc.
To date, Teva Pharmaceuticals USA, Inc., has not received any reports related to the product labeling.
The following products are included in the recall:
|
NDC |
Lot |
Expiration Date |
Strength |
Size |
|
51862-634-28 |
42617828 |
06/2023 |
100 mcg |
28 buccal tablets |
|
51862-634-28 |
100020465 |
01/2024 |
100 mcg |
28 buccal tablets |
|
51862-635-28 |
100020528 |
09/2024 |
200 mcg |
28 buccal tablets |
|
51862-635-28 |
100026699 |
11/2024 |
200 mcg |
28 buccal tablets |
|
51862-636-28 |
100020351 |
11/2024 |
400 mcg |
28 buccal tablets |
|
51862-636-28 |
100020522 |
09/2024 |
400 mcg |
28 buccal tablets |
|
51862-636-28 |
100026700 |
11/2024 |
400 mcg |
28 buccal tablets |
|
51862-637-28 |
42617831 |
06/2023 |
600 mcg |
28 buccal tablets |
|
51862-637-28 |
42619585 |
11/2023 |
600 mcg |
28 buccal tablets |
|
51862-637-28 |
100029649 |
11/2024 |
600 mcg |
28 buccal tablets |
|
51862-638-28 |
42617832 |
06/2023 |
800 mcg |
28 buccal tablets |
|
51862-638-28 |
42619530 |
08/2023 |
800 mcg |
28 buccal tablets |
|
51862-638-28 |
100020532 |
11/2024 |
800 mcg |
28 buccal tablets |
Teva Pharmaceuticals USA, Inc., alerted Mayne Pharma, Inc., on April 27, 2023, about the recalled lots and requested the return of the affected products. Instructions for returning the product are in Teva Pharmaceuticals USA, Inc.’s recall letter and consumer recall letter.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.