← RecallGuard
HomeRecalls

Cardinal Health Inc. Recall: Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60

Cardinal Health Inc. Recall: Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Cardinal Health Inc.; Product: Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-

Recalling firmCardinal Health Inc.
ProductBelbuca (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.
Reason for recallCGMP Deviations: Intermittent exposure to temperature excursion during storage.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionFL, GA, SC
Recall initiated20210315
Recall numberD-0448-2021
Categorydrug
StateOH
CountryUnited States

🔍 Search all recalls →