Sandoz has initiated a recall of 1 lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL single-dose syringes to the consumer level due to temperature excursion during shipment.
Enoxaparin sodium injection is a low molecular weight heparin indicated for the prophylaxis of deep vein thrombosis (DVT), treatment of acute DVT with or without pulmonary embolism, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) when concurrently administered with aspirin, and treatment of acute ST-segment elevation MI.
The recalled lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL; NDC Number 00781-3246-64; Lot number SAB06761A; expiration date 04/2023; date of manufacture 05/26/2021, was distributed nationwide to wholesalers and retailers in September and October 2021.
Exposure to higher temperatures may have significantly impacted the efficacy of the recalled product. To date, the Company has not received any reports of adverse events or injuries related to this recall.
Consumers should contact Sedgwick directly by phone at (844) 265-7389 or by email at [email protected]
Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program.
Sandoz, Inc. issues nationwide recall of one lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL due to temperature excursion during shipping. News release. Sandoz, Inc. December 1, 2021. https://www.us.sandoz.com/patients-customers/product-safety-notices.