The Recall Desk
ModerateFDA (Drugs)·D-0433-2021·Announced 2021-06-02

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.

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 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
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

Distributed in 3 states:

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 →

Same brand · BRILINTA