Recalls / Class II
Class IID-0869-2023
Product
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
- Brand name
- Buprenorphine
- Generic name
- Buprenorphine
- Active ingredient
- Buprenorphine Hydrochloride
- Route
- Sublingual
- NDCs
- 62756-459, 62756-460
- FDA application
- ANDA201760
- Affected lot / code info
- Lot #: DND1515A, Exp 08/24
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 12,336 bottles
- Distribution pattern
- Product was distributed to 19 distributors nationwide.
Timeline
- Recall initiated
- 2023-05-03
- FDA classified
- 2023-06-07
- Posted by FDA
- 2023-06-14
- Terminated
- 2024-01-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0869-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.