D-0768-2023 Class III Terminated
FDA drug recall D-0768-2023 was initiated by Teva Pharmaceuticals USA Inc on April 27, 2023 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Package Insert The recall status is terminated (terminated February 29, 2024). Affected quantity: 1272.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- April 27, 2023
- Termination Date
- February 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1272
Product Description
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Distribution Pattern
US Nationwide
Code Information
Lot#: 100020351, Exp 11/2024; 100020522, Exp 09/2024; 100026700, Exp 11/2024