BY DAVID J. NEAL
Syringe marking errors, which can lead to incorrect dosing, caused a recall of Enoxaparin Sodium Injection, a generic version of blood clot medication Lovenox.
The recall issued on Feb. 8 by Apotex, a Weston, Florida company, says some syringe barrels have 150 mg/ml Enoxaparin Sodium Injection markings instead of 100 mg/ml strength markings “and vice versa.”
Apotex says the problem goes back to the manufacturer, Gland Pharma Limited in India.
This drug is used to prevent the blood clots also called “deep vein thrombosis,” which can lead to the blood clots in the lungs also called “pulmonary embolisms.”
“Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications,” the FDA-posted recall alert says. “Alternative, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.”
Questions about recall
What’s recalled are batch No. CS008 (100 mg/ml) with NDC No. 60505-0795- 1 and UPC code (01)10360505079510 on the bottle; and batch No. CT003 (120 mg/0.8 ml, marked as 150 mg/ml) with NDC No. 60505-0796-0 and UPC code (01)10360505079602. Each comes in packs of 10 1 ml syringe doses.
If you’re a patient with either of these batches, Apotex advises you to contact your health care professional, then return the medication by getting a Recall Stock Response Form from Inmar Rx Solutions. Contact Inmar at 855-667-8717 or get the form at Inmar’s website.
If you have questions about this recall, contact Apotex at 800-706-5575, Monday through Friday, 8:30 a.m. to 5 p.m. or by email at UScustomerservice@Apotex.com.
If this or any other drug causes a medical problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.