Date: 03/15/2021
Product: 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.
Company: Cardinal Health Inc.
Recall Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Classification: Class II
Report Date: 20210602