Cardinal Health Recalls Belbuca Due to Temperature Excursions
Cardinal Health is recalling 96 cartons of Belbuca buccal film due to intermittent exposure to temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 96 cartons of Belbuca (buprenorphine hydrochloride) buccal film, 300 mcg, 60 pouches. The recall is due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by lot code 37674B and NDC 59385-023-60. The product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BELBUCA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 96
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 37674B
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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