ChemLifeIntel/Companies/Cardinal Health Inc.

Cardinal Health Inc.

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INTELLIGENCE

Showing 6 of 6 briefs on Cardinal Health Inc.

REGULATORY INTELLIGENCE·Recall

Cardinal Health's Webcol Alcohol Prep Pad Recall: A Class I Sterility Breach Demands Immediate Supply Chain Action

Cardinal Health 200, LLC has initiated a Class I recall of over 174 million boxes of Webcol Alcohol Prep pads due to *Paenibacillus phoenicis* contamination. This non-sterility event, impacting distribution across the United States, Puerto Rico, and Japan, necessitates immediate action from procurement and regulatory teams to assess inventory, mitigate patient risk, and secure alternative sterile medical supplies.

90-Day Activity

Cardinal HealthWish Isopropyl Alcohol

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2026-03-25 Recall

REGULATORY INTELLIGENCE·Recall

FDA Initiates Class II Recall for Sulfamethoxazole and Trimethoprim Due to Packaging Contamination

Cardinal Health 107, LLC faces a Class II FDA recall for Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg. The recall, initiated by The Harvard Drug Group LLC, stems from microorganism detection on auxiliary polyester coil packaging, not the drug itself. This nationwide U.S. distribution disruption highlights critical packaging supplier oversight and quality control needs, impacting procurement and supply chain continuity for this essential antibiotic.

90-Day Activity

Cardinal HealthSulfamethoxazole

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-09-17

REGULATORY INTELLIGENCE·Recall

Cardinal Health Inc. Initiates Class II Recall of Genentech's Xolair (Omalizumab) Due to Cold Chain Failure

Cardinal Health Inc. has initiated a Class II recall for four units of Genentech's Xolair (omalizumab) due to temperature excursions, indicating CGMP deviations. This incident highlights persistent cold chain vulnerabilities within Cardinal Health's distribution network, following similar recalls for XIGDUO XR and RECOMBINATE. Procurement and supply chain leaders must reassess third-party logistics risks for temperature-sensitive biologics.

90-Day Activity

Cardinal HealthXOLAIR

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2025-08-13▲ Trending signal

REGULATORY INTELLIGENCE·Recall

Cardinal Health Inc. Initiates Class II Recall for Genentech's Xolair (Omalizumab) Due to Cold Chain Failure

Cardinal Health Inc. has initiated a Class II recall for Genentech's Xolair (omalizumab injection) due to critical temperature excursions during storage. This event, involving 6 units, highlights persistent cold chain vulnerabilities within Cardinal Health's distribution network. For procurement and regulatory leaders, this underscores the imperative for stringent cold chain audits and diversified supplier strategies to safeguard sensitive biologic supply and ensure patient safety.

90-Day Activity

Cardinal HealthXOLAIR

RMRohan Mehta· Senior Supply Chain Intelligence Analyst

2025-08-13▲ Trending signal

REGULATORY INTELLIGENCE·Recall

Cardinal Health Faces FDA Class II Recall for RECOMBINATE Due to Repeated Temperature Excursions

Cardinal Health Inc. has initiated a Class II recall for RECOMBINATE, Antihemophilic Factor (Recombinant), 5 mL vials, impacting three units nationwide. The recall, D-0573-2025, stems from CGMP deviations related to product exposure to temperatures outside labeled storage requirements. This marks a concerning pattern, as Cardinal Health faced a similar temperature excursion recall in 2021, signaling systemic cold chain vulnerabilities for procurement and supply chain leaders.

90-Day Activity

Cardinal HealthAntihemophilic Factor, Pegylated (Mw 20000) Human Sequence RecombinantHSN N/A

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-08-13▲ Trending signal

REGULATORY INTELLIGENCE·Recall

Cardinal Health Inc. Faces FDA Class II Recall for XIGDUO XR Due to Storage Temperature Excursions

Cardinal Health Inc. faced a Class II recall for 664 bottles of XIGDUO XR (dapagliflozin/metformin HCl) due to CGMP deviations involving temperature excursions during storage across Florida, Georgia, and South Carolina. This terminated 2024-06-17 recall underscores the critical need for robust temperature control in pharmaceutical distribution, impacting supply chain integrity and regulatory compliance for all stakeholders.

90-Day Activity

Cardinal HealthXIGDUO XR

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2021-06-02