Recalls / Class II
Class IID-0449-2021
Product
Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA
- Brand name
- Belbuca
- Generic name
- Buprenorphine Hydrochloride
- Active ingredient
- Buprenorphine Hydrochloride
- Route
- Buccal
- NDCs
- 59385-021, 59385-022, 59385-023, 59385-024, 59385-025, 59385-026, 59385-027
- FDA application
- NDA207932
- Affected lot / code info
- BL6002004
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- BioDelivery Sciences International Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 47 cartons
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0449-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.