FDAFDA · Food and drugs·Recall number D-0448-2021
Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
Published June 2, 2021 · Recall initiated: March 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BELBUCA
- Manufacturer
- Cardinal Health Inc.
- Distributor
- FL, GA, SC
- Lot
- 37674B
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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