EzriCare Artificial Tears Health Risks
This is an information piece. No one should stop medical treatment based on this information herein. Instead, consult qualified healthcare providers, which we are not.
Ketterer, Browne, and Associates, LLC often deals with the intersection of healthcare and law. Late last month, the Centers For Disease Control and Prevention (“CDC”) identified another concern in this intersection. The Agency identified 55 cases of drug-resistant bacteria across 12 states.
CDC Issues Information Concerning EzriCare Artificial Tears
The common denominator in all 55 of these cases? One popular brand of eye drops and artificial tear products – EzriCare. The agency analyzed samples from May thru December of last year. It linked a possible source of the strain to opened EzriCare bottles.
Pseudomonas aeruginosa, the main bacterium here, has been harder to treat amid its increased resistance against even the most powerful antibiotics. Sadly, at least one death has already been linked to this outbreak. This prompted a strong response from the CDC and the FDA.
On the website ezricare-info.com, the company initially announced that they were unaware of the CDC’s investigation, and unaware of customer complaints or requests for recall. However, EzriCare warned, in no uncertain terms, to “DISCONTINUE USE of any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have…”
A recall subsequently followed suit. Now, let’s explore this recall, past eye drop recalls, and the potential legal recourse that could emerge in light of this product recall.
CDC Health Advisory – February 2022
On February 2nd, the CDC released a health advisory, summarizing findings from the investigation into EzriCare eye drops. The CDC identified the methods of sample collection, the 55 known cases of EzriCare-linked infection thus far. This occurred across 12 states where they discovered cases (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA, and WI).
The Agency recommends “Discontinue using EzriCare Artificial Tears, pending additional guidance from CDC and FDA.” We would also be remiss to neglect (paraphrasing) their additional public health patient recommendations regarding EzriCare:
- Patients who were previously prescribed or advised to use EzriCare artificial tears should consult their healthcare provider about alternative eye drops.
- Patients experiencing symptoms of eye infection after using EzriCare eye drops should seek prompt medical care ASAP.
The FDA Issued Notice
In light of this health advisory issued by the CDC, the Food and Drug Administration (“FDA”) is now cautioning consumers. It counsels against purchasing potentially contaminated batches of EzriCare eye drops. Global Pharma Healthcare, the parent company behind the development of EzriCare and Aru Pharma-distributed products, is now voluntarily recalling “all unexpired lots” of their eye drop products. The FDA seems to support this.
The Investigation into EzriCare Continues
Right now, the CDC and FDA are collaborating on the investigation and monitoring of the multistate outbreak. So far it seems it caused serious hospitalizations, permanent vision loss, and death. The consequences have been far-reaching and felt in states all across the country.
Specifics Concerning the EzriCare Products
Global Pharma has notified the distributors of its eye drop products: Delsam Pharma and Aru Pharma. It recommended customers stop using products from either distributor. Questions or concerns can go to:
- Aru Pharma: 518-738-7602 or firstname.lastname@example.org
- Delsam Pharma: 866-826-1309 or email@example.com
If you are experiencing adverse serious health reactions from EzriCare artificial tears, you can also report them to the FDA online. Unfortunately, this isn’t the first case of an artificial tears brand breaching consumer trust.
Alcon Laboratories was hit with their most recent class action claim in late 2022, concerning an alleged claim of misleading labeling on their Pataday brand eye drops. Likewise, in early 2022, eye drug manufacturer Restasis settled an antitrust monopoly case in court for $30 million. Though these cases concern different areas of law, it is interesting to explore other issues in this industry. So far, at least one class action is trying to hold them liable, as well as these additional defendants:
- Ezricare LLC
- Ezrirx LLC
- Delsam Pharma LLC
- Global Pharma Healthcare Private LTD
- Aru Pharma Inc.
The Companies Involved Likely Faces Personal Injury Suits Concerning Its EzriCare Eyedrops
There appear to have been repeated violations of the FDA’s current regulations concerning Good Manufacturing Practice, or GMPs. These suspected violations could be root causes for the current problems. These latest issues with the EzriCare eye drops could open Global Pharma and EzriCare up to future negligence and product liability claims, including the following deviations:
- Issues with the formulation of the product;
- “lack of appropriate microbial testing;”
- Inadequate preservative ingredients; and
- Insufficient controls for tamper-evident products.
KBA is Here to Help
We do not advocate stopping medical treatment without speaking with a medical provider. For legal advice, licensed attorneys, such as those at KBA Attorneys, have decades of experience navigating the complexities of product liability claims. Indeed, attorneys at KBA have handled outbreaks like this before. We have worked on food poisoning cases and viral infections from unsanitary distributors, including the infamous, NECC outbreak.
If you or a loved one suffered an adverse medical reaction as a result of using EzriCare eye drop products, you might be entitled to receive compensation. To learn more about our team and how we might be able to help you, contact our office by clicking here..
This post is informational. References to the CDC and FDA do not suggest a relationship with these agencies or endorsement of the views herein.