Belbuca Film, Soluble
FDA Recall NDC 59385-024
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Belbuca (NDC 59385-024). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Biodelivery Sciences International Inc. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
96 cartons
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
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.
Batch or Lot Expiration Information
Lot# 37674B
Affected Packages Involved in this Recall
59385-021-01Product
59385-021-60Product
59385-022-01Product
59385-022-60Product
59385-023-01Product
59385-023-60Product
59385-024-01Product
59385-024-60Product
59385-025-01Product
59385-025-60Product
59385-026-01Product
59385-026-60Product
59385-027-01Product
59385-027-60Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
47 cartons
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA
Batch or Lot Expiration Information
Lot# BL6002004
Affected Packages Involved in this Recall
59385-021-01Product
59385-021-60Product
59385-022-01Product
59385-022-60Product
59385-023-01Product
59385-023-60Product
59385-024-01Product
59385-024-60Product
59385-025-01Product
59385-025-60Product
59385-026-01Product
59385-026-60Product
59385-027-01Product
59385-027-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
