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FDA Investigation Results Slam Artificial Tears Manufacturer

FDA Investigation Results Slam Artificial Tears Manufacturer

You deserve answers when you are harmed by an unsafe product, especially pharmaceuticals that the manufacturer claims are safe. When a manufacturer or distributor carelessly releases a dangerous product into the stream of commerce, you may be entitled to compensation for your injuries. This is the scenario that Global Pharma Healthcare Private Limited faces after the Food and Drug Administration (FDA) found troubling reasons for recalls. The FDA and the Centers for Disease Control and Prevention (CDC) are investigating a slew of infections that epidemiologic evidence has linked to EzriCare Artificial Tears.

The multidrug-resistant pathogen found in these products is a strain of Pseudomonas aeruginosa bacteria. Fifty-five patients in twelve states have suffered serious infections leading to hospitalization. Unfortunately, one death has occurred.

If you have suffered a serious infection or blindness after using any of these products, it is important to know that you have legal options. Contact Jan Dils, Attorneys at Law today to discuss your situation with a compassionate legal advocate.

The FDA Findings

The FDA continues to advise medical practitioners and consumers against purchasing or using EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Eye Ointment because of potential contamination. The FDA also recommended a recall, which Global Pharma initiated voluntarily. The FDA investigation found:

  • Global Pharma violated current manufacturing practices (CGMP)
  • The artificial tears and eye ointment products lacked appropriate microbial testing
  • Ophthalmic drugs are manufactured and distributed in multiuse bottles with inadequate preservatives causing formulation issues
  • Proper controls are lacking because packing is not tamper-evident

Consumers experiencing symptoms of eye infections after using Global Pharma’s products should seek immediate medical help. After getting evaluated by a medical professional, contact our firm to discuss how we can aggressively fight to get you compensated.

Legal Recourse After Defective Product Injuries

The FDA findings have put Global Pharma in the crosshairs for lawsuits based on negligence or strict liability for problems in the manufacturing phase.

An attorney from our firm can help demonstrate that Global Pharma had a duty to produce a product as safe as any responsible manufacturer would. Then, she can argue that Global Pharma breached its duty by acting carelessly or intentionally, and the tainted, sub-standard product caused your injuries.

Strict liability allows your attorney to circumvent proving negligence if she can establish specific facts. Thus, Global Pharma can be held accountable under strict liability if the eyedrops or ointment were defective when sold, the products were used as intended and were not modified, and the products directly and foreseeably caused your injuries. If any of these faulty products have hurt you, do not hesitate to contact our firm.

The FDA Investigation Bolsters Claims About Problematic Products

The FDA’s role in proving a negligence or strict liability claim against Global Pharma is like the role of an expert witness. The FDA has already reported that Global Pharma violated good manufacturing practices. Pseudomonas aeruginosa bacteria thrive in most areas of the world, especially in moist environments. It is extremely good at infiltrating humans through damaged tissue, including irritated eyes.

The company’s artificial tears (carboxymethylcellulose sodium) and ointments are meant to protect a user’s eyes from further irritation, relieve dryness, and soothe after exposure to sun and wind. Failing to test products for microbial contamination and failing to adequately use preservatives that allowed the bacteria to grow is detrimental to Global Pharma’s position as a defendant in negligence or strict liability lawsuits. Our attorneys want to hear your story. We can hold Global Pharma responsible for injuries you suffered using its products.

Discuss You Claim With an Attorney Today

Global Pharma Healthcare Private Limited failed to ensure that its products were safe for their intended use. As a result, far too many patients are suffering, and one person has passed away.

Injury as a result of taking these medications is actionable. If you sustained an infection after using EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, or Delsam Pharma’s Artificial Eye Ointment, legal recourse may be available to you.

At Jan Dils, Attorneys at Law, we fight tirelessly to hold negligent manufacturers accountable for their actions. Allow us to take the lead in securing the compensation you deserve for your losses. Your first consultation is always free, so you have nothing to lose by reaching out today.

Note: The recalled products display the following product codes:

EzriCare NDC 79503-0101-15, UPC 3 79503 10115 7

Delsam NDC 72570-121-15, UPC-72570-0121-15

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Jan Dils, Attorneys at Law

Jan Dils, Attorneys at Law
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