FDA recall D-0869-2023
SUN PHARMACEUTICAL INDUSTRIES INC · Class II · drug
Product
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Reason for recall
CGMP Deviations
Distribution
Product was distributed to 19 distributors nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2023-05-03
- Report date
- 2023-06-14
- Termination date
- 2024-01-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Princeton, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2023