Recalls / Class III
Class IIID-0768-2023
Product
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
- Affected lot / code info
- Lot#: 100020351, Exp 11/2024; 100020522, Exp 09/2024; 100026700, Exp 11/2024
Why it was recalled
Labeling: Incorrect or Missing Package Insert
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 1272
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2023-04-27
- FDA classified
- 2023-05-24
- Posted by FDA
- 2023-05-31
- Terminated
- 2024-02-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0768-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.