Cardinal Health Recalls Brilinta Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 1,278 bottles of Brilinta (ticagrelor) 60 mg tablets due to intermittent exposure to temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 storage conditions (temperature excursions) which is a low-risk contamination or quality issue without reported illness, fitting the Moderate criteria.
Plain-English summary
Cardinal Health Inc. is recalling 1,278 bottles of Brilinta (ticagrelor) 60 mg tablets. The recall is due to current good manufacturing practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by lot code MP0138 and NDC 0186-0776-60. The tablets were manufactured for AstraZeneca LP. The distribution pattern for this recall includes Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- BRILINTA (TICAGRELOR)
- Brand
- BRILINTA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,278
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)
- MP0138
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.
See all 198 products in this recall →Related recalls
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