Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28

Recall Number: D-0770-2023

Firm: Teva Pharmaceuticals USA Inc

Classification: Class III

Status: Terminated

Report Date: 20230531

Initiation Date: 20230427

Termination Date: 20240229

Labeling: Incorrect or Missing Package Insert

Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28