Deep Vein Thrombosis Medication Recalled: Here’s What to Know Now


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If you have one of the recalled medications talk to your physician. Westend61/Getty Images
  • A medication commonly used to treat deep vein thrombosis, Enoxaparin Sodium Injection, USP, has been voluntarily recalled due to a packaging error in which the labels don’t accurately list the correct dose.
  • Taking the incorrect dose of the injection can lead to bleeding and clotting complications.
  • Doctors don’t recommend skipping a dose, so if you have a bottle included in the recall, talk with your doctor immediately.

A medication commonly used to treat deep vein thrombosis, Enoxaparin Sodium Injection, USP, has been voluntarily recalled due to a packaging error in which the labels don’t accurately list the correct dose.

The recallTrusted Source, which was issued by pharmaceutical company Apotex Corp. Tuesday, Feb. 2, states that syringe barrels containing 150 mg/mL are mislabeled as containing 100mg/mL, and vice versa.

Enoxaparin sodium is an anticoagulant used to treat pulmonary embolism, blood clotting disorders, and deep vein thrombosis (DVT) — a condition in which blood clots form in veins located deep within the body.

When administered with aspirin, it can help prevent angina (chest pain) and heart attacks.

Taking the incorrect dose of the injection can lead to bleeding and clotting complications.

“Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients,” the recall states.

The affected products were produced in two batches: CS008 and CT003.

The batches were distributed by Apotex Corp. nationwide to wholesalers and warehousing chains.

If a patient prescribed a 150 mg/mL bottle received a mislabeled bottle that contained 100 mg/mL, they could receive 2 mg of enoxaparin rather than 2.5 mg of enoxaparin, the recall explains.

If a patient who typically uses a 100 mg/mL bottle received a mislabeled bottle that contained 150 mg/mL, they might end up taking 3.75 mg of enoxaparin instead of 3 mg of enoxaparin.

The prescribed dosing of enoxaparin sodium is based off of a person’s age, weight, condition being treated, severity of the condition, overall health, and how well they tolerate the medication.

The injection is administered either once or twice a day.

Taking a higher dose of enoxaparin sodium can lead to bleeding complications.

Some patients could experience symptoms like bruises on mucosal or skin surfaces, blood in urine or stool, said Dr. Natalia Neparidze, a Yale Medicine hematologist and assistant professor of medicine at Yale School of Medicine.

Too low of a dose can lead to clotting.

“Taking too little of the intended dose of the drug will result in suboptimal, inadequate anticoagulation, putting patients at risk for recurrent or worsening thrombosis, such as deep venous thrombosis or pulmonary embolism,” Neparidze said.

Taking a lower dose may cause pain or swelling in the extremities in patients with deep vein thrombosis.

Dr. Britt Tonnessen, a Yale Medicine vascular and endovascular surgeon and associate professor of surgery at Yale School of Medicine, said the warning signs of a clot include shortness of breath or pain with breathing, racing heart, or stroke.

It’s unlikely that someone could detect their dose is off, Tonnessen added.

According to Neparidze, very minor dosing differences may not cause significant bleeding or clotting complications. But if the incorrect dose is continually taken, complications may occur.

Because the dose is based on weight, people who are under or overweight may be more sensitive to changes in dosing.

“While injecting a reduced dose on a single or a few occasions is unlikely to cause harm, continued use of a lower dose than prescribed could lead to a recurrence of blood clots,” Tonnessen said.

Anyone with a syringe barrel from the affected batches should immediately talk with a doctor and have the medication replaced with the correct dose, Neparidze said.

Doctors don’t recommend skipping a dose.

“In the event that there will be a delay in receiving the new batch of medication, patients should contact their doctor to make arrangements for alternative treatment in the interim,” Tonnessen said.

Anyone who received the affected medication should contact Inmar Rx Solutions at 1-855-667-8717 to arrange a return, the recall states.

Any adverse events should be reported to the FDA’s MedWatch Adverse Event ReportingTrusted Source program.

A medication commonly used to treat deep vein thrombosis, Enoxaparin Sodium Injection, USP, has been voluntarily recalled due to a packaging error in which the labels don’t accurately list the correct dose.

Taking the incorrect dose of the injection can lead to bleeding and clotting complications.

Doctors don’t recommend skipping a dose, so if you have a bottle included in the recall, talk with your doctor immediately.

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