FDA-Drug2021-06-02Class II
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.
Cardinal Health Inc.
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sold states
FL, GA, SC
Affected count
96 cartons
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2021Don't want to check this manually?
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