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.
Recall Number: D-0448-2021
Firm: Cardinal Health Inc.
Classification: Class II
Status: Terminated
Report Date: 20210602
Initiation Date: 20210315
Termination Date: 20240617
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product Description
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.