D-0869-2023 Class II Terminated
FDA drug recall D-0869-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on May 3, 2023 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated January 9, 2024). Affected quantity: 12,336 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 14, 2023
- Initiation Date
- May 3, 2023
- Termination Date
- January 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,336 bottles
Product Description
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Reason for Recall
CGMP Deviations
Distribution Pattern
Product was distributed to 19 distributors nationwide.
Code Information
Lot #: DND1515A, Exp 08/24