Cardinal Health Inc.: Drug Recall

Recall #D-0500-2021 · 03/15/2021

Class II: Risk

Recall Details

Recall Number: D-0500-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Cardinal Health Inc.
Status: Terminated
Date Initiated: 03/15/2021
Location: Dublin, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 453 bottles

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Product Description

Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan

Distribution Pattern

FL, GA, SC

Other Recalls by Cardinal Health Inc.

Class II: Risk 08/05/2025

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 04/09/2025

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

View all recalls by Cardinal Health Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.