Drug product
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
D-0869-2023
Product summary
- Event
- Event 92256
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,336 bottles
- Official record key
drug-enforcement:D-0869-2023
Official wording
Reason: CGMP Deviations
Code information: Lot #: DND1515A, Exp 08/24
Distribution pattern: Product was distributed to 19 distributors nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations