Enoxaparin Sodium Injection recall active as of 2025. Cardinal Health and Sandoz Inc. distributed the product in Kansas. Bags labeled 80 mg/0.8 mL contained 30 mg/0.3 mL doses. Health authorities urge immediate stop-use and guidance from providers.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Consumers and healthcare providers should stop using this product immediately. Contact Cardinal Health Inc. or your healthcare provider for guidance. Notification method: Letter
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Enoxaparin Sodium Injection is an anticoagulant used to prevent and treat deep vein thrombosis and pulmonary embolism. It is administered by healthcare professionals.
Mislabeled bags could result in incorrect dosing, potentially causing under-anticoagulation or over-anticoagulation with risk of bleeding.
This recall is not stated as part of a broader industry pattern.
Immediate action required for clinicians and patients using affected lots; risk to patient safety if incorrect dose is administered.
FDA enforcement page for D-0597-2025; recall letters from Cardinal Health and Sandoz.
Refund/replacement processes follow agency guidance in recall letters; timeline varies by institution.
Keep recall letter, log lot numbers, capture communications with supplier and pharmacy
Product: Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL. Packaging: 0.3 mL prefilled syringes in bags of 5. Outer label NDC 55154-3543-5. Inner label NDC 0781-3238-01. Distributor: Cardinal Health Inc. and Sandoz Inc. Route: Rx Only.
No injuries or incidents have been reported in the recall notice.
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