Sagent Pharmaceuticals Docetaxel Injection Injury Lawsuit Lawyers

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter

Sagent Pharmaceuticals has recently announced a voluntary nationwide recall of two specific lots of Docetaxel Injection, USP. The recall, initiated on May 28, 2024, addresses concerns over the potential presence of particulate matter within the injectable product. The affected lots include 80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials, distributed between October 11, 2023, and April 11, 2024.

The decision to recall these products was prompted by a customer complaint regarding particulate matter originating from the stopper in the drug product. This particulate contamination poses significant health risks when administered intravenously. The complications arising from injecting particles can be severe, potentially leading to inflammation of veins, granulomas, and blockages in critical blood vessels, such as those in the heart, lungs, or brain. Such blockages can result in strokes or life-threatening blood clot events. The severity and frequency of these adverse events may vary based on factors like the size and number of particles, the patient’s health condition, and the presence of vascular anomalies.

To date, Sagent Pharmaceuticals has not received any reports of adverse events related to this recall. However, the company is taking proactive measures to mitigate any potential risks. Customers who have purchased the affected lots are being notified through FedEx packages, which include instructions for the return of the recalled products. Customers are advised to immediately examine their inventory, quarantine the recalled lots, and discontinue their distribution. Further, customers who may have redistributed these products are requested to notify their customers and facilitate the return process.

Consumers, distributors, and retailers in possession of the recalled product are urged to cease using the product and return it. Detailed information about the return process and necessary documentation is available on Sagent Pharmaceuticals’ official website. Customers with questions regarding the return of unused products can contact Sagent’s customer call center at (866) 625-1618, available Monday through Friday from 8 am to 5 pm CST, option 1. Healthcare professionals with medical inquiries about Docetaxel Injection, USP, can reach out to Medical Affairs at the same number, option 3, during the same hours.

Adverse reactions or quality issues experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, via regular mail, or by fax. Instructions for submitting these reports are available on the FDA’s website or by calling 1-800-332-1088 to request a reporting form.

Harm and Injury from Contaminated Products and Legal Recourse

The presence of particulate matter in injectable drugs like Docetaxel Injection, USP can cause significant harm to patients. When such particles enter the bloodstream, they can lead to a range of adverse health effects. These include inflammation of the veins, formation of granulomas, and even blockages in vital blood vessels, potentially resulting in strokes or other life-threatening conditions. The risk is particularly high for patients with existing health issues, such as compromised organ function or vascular anomalies.

Victims affected by such contaminated products may seek legal recourse to recover damages. Filing a lawsuit against the manufacturer, such as Sagent Pharmaceuticals in this case, allows victims to hold the company accountable for the harm caused by their product. The legal process typically begins with a consultation with an experienced attorney who can evaluate the merits of the case. The attorney will gather evidence, including medical records and expert testimony, to build a strong case demonstrating how the contaminated product led to the victim’s injuries.

Throughout the lawsuit process, having an attorney is crucial. Legal professionals can navigate the complexities of product liability law, ensuring that all procedural requirements are met and that the case is presented effectively in court. They can also negotiate settlements with the manufacturer or their insurance company, aiming to secure compensation for medical expenses, lost wages, pain and suffering, and other damages.

Victims of such product-related injuries can potentially recover various forms of damages through a lawsuit. Compensatory damages are intended to cover direct costs, such as medical bills and lost income due to inability to work. Non-economic damages may be awarded for pain and suffering, emotional distress, and reduced quality of life. In some cases, punitive damages may also be pursued to punish the manufacturer for particularly egregious conduct and to deter similar future actions.