Drug Safety Alerts

Enoxaparin Voluntary Recall

12/2/2021

On December 2, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Enoxaparin Sodium Injection, 40 mg/0.4 mL NDC # 00781-3246-64 manufactured by Sandoz, Inc. This recall was issued due to a temperature excursion during shipment. This recall affects lot number SAB06761A exp. 04/2023.

Please note: This recall was originally issued to the retail-level on November 23, 2021. The recall was issued to consumer level on December 1, 2021.

This could be a health hazard or safety risk to patients using product affected by this recall.

The exposure to higher temperatures may have significantly impacted the recalled product’s (lot SAB06761A) effectiveness and thus there may be reasonable probability of risk for patients with health conditions that the product is intended to treat. Such patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots to the lung or death as a result of the underlying condition. Sandoz reports that as of the date of recall, it has not received any reports of adverse events or injuries related to this recall.

The product is used for prevention of deep vein thrombosis (DVT) 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 ten 0.4 mL syringes.

Consumers should stop taking the recalled product and immediately consult with their physician to obtain another prescription. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about the Enoxaparin Sodium Injection, 40 mg/0.4 mL, please call Sandoz at 1-800-525-8747 or email qa.drugsafety@sandoz.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov/.