D-0448-2021 Class II Terminated
FDA drug recall D-0448-2021 was initiated by Cardinal Health Inc. on March 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. The recall status is terminated (terminated June 17, 2024). Affected quantity: 96 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 cartons
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.
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution Pattern
FL, GA, SC
Code Information
37674B