Enoxaparin Recall: Mislabeled Injectable Blood Thinner Could Result In 'Inaccurate Dose Administration'

A pharmaceutical company is recalling two batches of its enoxaparin sodium injection because of a "packaging error." Some of the syringes could lead to incorrect dose administration to patients.

Apotex discovered the problem while investigating a customer complaint, the company said on the Food and Drug Administration (FDA) website. The recalled batches were mislabeled and could result in patients getting a higher or lower dosage of the drug than intended.

Because of the error, a patient could get a lower dose of 2 milligrams (7.05 ounces) of enoxaparin instead of 2.5 mg, or a higher 3.75 mg of enoxaparin instead of just 3 mg.

Enoxaparin sodium is a blood thinner, and it is used for various conditions such as deep vein thrombosis (DVT). The company said getting a higher dose of the enoxaparin sodium injection could result in "bleeding complications," while a lower dose could cause "blood clotting conditions."

Apotex has urged those who have purchased the affected product to immediately contact their pharmacy and healthcare provider for advice but to "not interrupt their therapy." They should also return the affected products by contacting the company. The UPC codes and NDC numbers were shared on the FDA website.

In 2020, Apotex was also among the list of companies that recalled the diabetes drug metformin because of the presence of cancer-causing N-Nitrosodimethylamine (NDMA).

Enoxaparin

It is an injectable medicine that works by preventing the formation of the substances that cause blood clots. According to the FDA, blood clots in the leg or any other part of the body can "travel to the lungs" and cause major complications and even death.

Apart from being a prophylaxis for conditions such as DVT, enoxaparin is given to patients after certain surgeries and those who are confined to bed. When used with aspirin, enoxaparin can also prevent complications of heart attacks and chest pain.

According to the U.S. National Library of Medicine (NLM), it is important to follow enoxaparin prescriptions "exactly as directed" and even ask the doctor or pharmacist if there's anything you don't understand.

"Do not inject more or less of it or inject it more often than prescribed by your doctor," the NLM said.

Patients should also not stop taking the drug without consulting their doctor.

Anyone suspected of overdosing should call the poison control helpline, or 911 if the victim has already collapsed, is seizing, cannot be awakened or is having trouble breathing.