Cardinal Health Recalls Briviact Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 101 bottles of Briviact (brivaracetam) 50 mg tablets 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 the hazard involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 101 bottles of Briviact (brivaracetam) 50 mg tablets, 60-count bottles, prescription only. The product is manufactured for UCB, Inc. and carries NDC 50474-570-66. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code is 309750.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to continue using the medication or obtain a replacement. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BRIVIACT (BRIVARACETAM)
- Brand
- BRIVIACT
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 101
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)
- 309750
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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