Status
Terminated
Drug Enforcement D-0770-2023
Labeling: Incorrect or Missing Package Insert
Classification
Class III
Report Date
May 31, 2023
Termination Date
February 29, 2024
Product Information
- Product description
- 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
- Product quantity
- 3032
- Reason for recall
- Labeling: Incorrect or Missing Package Insert
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Address
-
400 Interpace Pkwy Bldg A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0770-2023
- Event ID
- 92133
- Recall initiation date
- April 27, 2023
- Center classification date
- May 24, 2023
- Code info
- Lot#: 42617832, Exp 06/2023; 42619530, Exp 08/2023; 100020532, Exp 11/2024
- More code info
- —