Drug product
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
D-0767-2023
Product summary
- Event
- Event 92133
- Status
- Terminated
- Classification
- Class III
- Quantity
- 397
- Official record key
drug-enforcement:D-0767-2023
Official wording
Reason: Labeling: Incorrect or Missing Package Insert
Code information: Lot #: 100020528, Exp 09/2024; 100026699, Exp 11/2024
Distribution pattern: US Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing