Cardinal Health Inc.: Drug Recall

Recall #D-0488-2021 · 03/15/2021

Class II: Risk

Recall Details

Recall Number: D-0488-2021
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: 54 bottles

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Product Description

FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117

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.