The Recall Desk
ModerateFDA (Drugs)·D-0500-2021·Announced 2021-06-02

Cardinal Health Recalls Livalo Tablets Due to Temperature Excursions

Cardinal Health is recalling 453 bottles of Livalo (pitavastatin calcium) 2 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 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 453 bottles of Livalo (pitavastatin calcium) 2 mg tablets. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected product is distributed in Florida, Georgia, and South Carolina. The specific code information for the recalled items is 3193479. Livalo is a prescription medication manufactured under license from Kowa Company, Limited, with tablets manufactured by Patheon, Inc. or Kowa Company, Ltd.

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 Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LIVALO (PITAVASTATIN CALCIUM)
Brand
LIVALO
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
453

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)

  • 3193479

UPCs (3)

  • 0366869204905
  • 0366869404909
  • 0366869104908

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 →

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