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Sandoz Recalls One Lot of Enoxaparin

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Article

A temperature change during shipping could impact the product’s effectiveness. Enoxaparin is used to prevent deep vein thrombosis.

Sandoz, a division of Novartis, is recalling one lot of Enoxaparin Sodium Injection 40 mg/0.4 mL single dose syringes. A portion of the effected lot — SAB06761A with an expiration date of April 202 — experienced a temperature change during shipment. The effected lot was shipped in September and October 2021.

The exposure to higher temperatures may have impacted enoxaparin’s effectiveness, exposing patients to the risk for blood clots, swelling, stroke, or death a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries.

The product is used to prevent deep vein thrombosis, a condition that occurs when a blood clot forms in a deep vein, usually in the legs that can occur after surgeries or in patients with restricted mobility during illness; or prevention of complications associated with heart attacks.

The product is packaged in cartons containing 10 0.4 mL syringes with NDC 0781-3246-64.

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