Nationwide Recall of Sodium Injection for Temperature Excursion


Company Announcement Date:
December 01, 2021
FDA Publish Date:
December 02, 2021
Product Type:
Reason for Announcement:
Exposure to high temperatures may have impacted product effectiveness.
Company Name:
Sandoz, Inc.
Brand Name:
Product Description:
Enoxaparin Sodium Injection

Company Announcement

FOR IMMEDIATE RELEASE – December 1, 2021 – Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021.

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. To date, Sandoz 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, NDC 0781-3246-64. Enoxaparin Sodium Injection was distributed Nationwide in the USA to wholesalers and retailers.

Product Name NDC Number Lot
Date of
Enoxaparin Sodium
Injection, USP 40
mg/0.4 mL
00781-3246-64 SAB06761A 04/2023 05/26/2021

Please note: this recall is specific to only one batch (SAB06761A) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL SKU.

Any product returned that is not associated with this recall will be destroyed and no credit issued.

Sandoz has already notified its wholesalers and retailers by mail and is arranging for return of all recalled product.

Consumers who have Enoxaparin Sodium Injection, USP 40 mg/0.4 mL (NDC 00781-3246-64 and Lot number SAB06761A) which is being recalled, should stop taking the recalled product, immediately consult with their physician to attain another prescription, and return the product where originally purchased. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Read the full report here.

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