Apotex Corp. has voluntarily pulled off Enoxaparin Sodium Injection, USP, from the market due to a packaging error which has resulted in some syringe barrels having an incorrect dosage listed.
The mislabeling of the syringe barrel was discovered during a customer complaint investigation.
In some cases, when customer complaints become too massive, they fuel lawsuits filed against companies who manufacture potentially faulty medical devices.
In the Paragard lawsuits, for instance, plaintiffs have filed complaints due to the complications they suffered from using the birth control device.
A number of women claim that the Paragard IUD is prone to breaking. When they had it removed, that’s when they started suffering from a wide range of medical issues such as fractures, heavy bleeding, and ectopic pregnancy, just to name a few.
Problems with medical devices, no matter how small, can bring harm to patients. Continue reading to find out how this latest recall is an embodiment of that statement.
What Is Enoxaparin Sodium Injection Used For?
Enoxaparin Sodium Injection, USP, is a medication commonly used to treat blood disorders like pulmonary embolism and deep vein thrombosis (DVT), which is the formation of a blood clot in a vein situated deep within the body.
It can also be used for treatment of acute deep vein thrombosis, and when taken with aspirin, it can help prevent unstable angina (increasing, unpredictable chest pain).
These Are The Affected Products
The recall, which was issued on Feb. 2 by the pharmaceutical company Apotex Corp., states that syringe barrels which have 150 mg/mL markings were mistakenly labeled with 100 mg/mL markings and vice versa.
The affected lots were produced in two batches: CS008 and CT003.
These batches of Enoxaparin Sodium Injection, USP were distributed by Apotex Corp. in the USA to wholesalers and warehousing chains nationwide.
The company is now in the process of notifying these establishments about the recall through a notification letter and is also currently arranging for the return of all recalled products.
What Happens When You Take The Incorrect Dose?
According to the recall, if patients happen to receive a syringe with an incorrect marking of 150 mg/mL but actually contains 100 mg/mL, they could end up taking 2 mg of Enoxaparin instead of 2.5 mg of Enoxaparin.
On the other hand, if they end up receiving a mislabeled bottle that contains 150 mg/mL, they could receive 3.75 mg of Enoxaparin instead of 3 mg of Enoxaparin.
Since the prescription of enoxaparin sodium is based on a patient’s weight, age, severity of the condition, and overall health, both an excess and an inadequacy in dosage might be harmful to patients.
“Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications,” the FDA announcement on the recall stated.
On the other hand, according to the agency, if the dose received is less than what is prescribed, the patient is likely to develop some blood clotting conditions.
What You Can Do
For anyone who has received a syringe barrel from either of the two affected batches of Enoxaparin Sodium Injection, USP, the FDA recommends contacting their local pharmacy.
According to the FDA announcement, individuals should not skip a dose and should immediately contact their health care provider for medical advice and possible replacement of the medication with the correct dose.
Patients who have received the affected products should contact Inmar Rx Solutions at 1-855-667-8717 to arrange a return, the recall states.
To date, Apotex Corp. has not received any reports of adverse events linked to the use of the impacted products from the two batches.
However, if you or someone you know has experienced problems or adverse reactions with the use of Enoxaparin Sodium Injection, USP, you should immediately report it to the FDA’s MedWatch Adverse Event Reporting program.