Drug Safety Alerts

Enoxaparin Sodium Injection Consumer-Level Recall

2/03/2021

On February 2, 2021, Apotex issued a consumer-level recall of Enoxaparin Sodium Injection. This recall was issued because each batch was manufactured with the incorrect barrels of syringes. Health Hazard Assessment concluded that no serious adverse effects are anticipated from exposure to slightly higher doses of enoxaparin. However, because of different barrel graduation marks, the possibility of miscalculation and inaccurate dose administration to patients still exists.

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

A complete list of the affected products and lot numbers is provided here.

Apotex advises that patients who have received impacted lots of Enoxaparin Sodium Injection should not interrupt their therapy and should contact their health care provider for medical advice. Patients should obtain replacement therapy before returning the impacted product.

CVS Caremark® Response:

Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please contact Apotex at 1-800-706-5575, Monday through Friday, 8:30 am to 5:00 pm (ET) or visit https://www1.apotex.com.

You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.