FDA Eye Drops Recall Lawyer
FDA Issues Warning to Consumers Using EzriCare or Delsam Pharma’s Artificial Tears
The U.S. Food and Drug Administration (FDA) has partnered with the Center for Disease Control (CDC) and state and local health departments after a number of infections were linked to the use of EzriCare or Delsam Pharma’s Artificial Tears eye drops. Over 55 patients in 12 different states were diagnosed with a rare strain of the Pseudomonas aeruginosa bacteria. The bacteria is known to be antibiotic-resistant and can lead to severe infections and even death.
The FDA recommended Global Pharma Healthcare issue a voluntary recall based on the company’s current good manufacturing practice (CGMP) violations. These violations included a lack of appropriate microbial testing, inadequate preservatives in multi-use bottles, and a need for proper controls concerning tamper-evident packaging. The nationwide recall was issued on February 2nd, 2023.
FDA Issues Additional Recall for Apotex Corp. and Pharmedica Eye Drops
Shortly after the EzriCare and Delsam Pharma’s Artificial Tears recall was announced, Apotex Corp. prescription eye drops and Pharmedica’s Purely Soothing Drops issued additional recalls. According to the FDA, the recalls were issued for Apotex Corp. Brimonidine Tartrate Ophthalmic Solution and Purely Soothing, 15% MSM Drops due to cracks that developed in some of the bottle caps allowing for potential contamination and non-sterility.
The timeline of the recall highlights the urgency with which the FDA acted to protect the public.
- On January 20th, 2023, the Centers for Disease Control and Prevention (CDC) announced that the eye drops were linked to over 50 serious bacterial infections in 12 states.
- January 24th, 2023, EzriCare publicly acknowledged the potential contamination for the first time, issuing a statement on its website claiming that it had not received any formal notice from the CDC or any other regulatory authority.
- A week later, on February 1st, 2023, the company announced that it had stopped any further distribution or sale of the contaminated eye drops and contacted the CDC and FDA about the issue.
- February 21st, 2023, the FDA issued an additional warning to consumers urging them not to use Global Pharma’s Artificial Eye Ointment.
- Delsam Pharma issued a voluntary recall for their Artificial Eye Ointment due to possible microbial contamination on February 24th, 2023.
- On March 1st, 2023, Apotex Corp. issued a voluntary nationwide recall of their Brimonidine Tartrate Ophthalmic Solution eye drops due to cracks that had developed in some of the eye drop caps and the potential lack of sterility.
- Two days later, Purely Soothing 15% MSM Drops, manufactured in Phoenix, Arizona, by Pharmedica USA LLC, also issued a voluntary recall due to non-sterility.
Pseudomonas Aeruginosa Bacteria Found in Eye Drops Manufactured by Global Pharma Healthcare
Pseudomonas aeruginosa bacteria has been found in artificial tears manufactured by Global Pharma, raising consumer concerns. When this dangerous bacteria enters directly into the eye, it can cause serious infections. Due to its resistance to antibiotics, it can be challenging to treat and can cause eye infections and even vision loss.
How the bacteria got into the EzriCare Artificial Tears is not yet clear, but it is believed that the contamination may have occurred in the manufacturing facility. This can happen when the production environment is not kept clean and disinfected or when the raw materials used are not properly stored or handled.
Another possible explanation is that bacterial contamination may have occurred during packaging or distribution. This can happen when the eye drops come into contact with contaminated surfaces or equipment during production.
It’s crucial for those affected by the FDA eye drop recall to receive prompt medical care and seek guidance from a knowledgeable attorney to understand their legal rights.
Information on Eye Drops Involved in the FDA Recall
The recent recall of eye drops by the FDA has caused concern among many consumers who use these products regularly. The two brands of eye drops involved in the FDA recall are EzriCare eye drops and Delsam Pharma’s Artificial Tears. These products were sold at Walmart and were also available for purchase nationwide on Amazon.
To determine if the eye drops you purchased are part of the recall, you need to verify the National Drug Code (NDC) and Universal Product Code (UPC). The eye drops were packaged in a bottle with a safety seal. You can locate the NDC and UPC on the outside of the box. The NDC and UPC are unique identification numbers assigned to each medication product.
EzriCare NDC 79503-0101-15, UPC 3 79503 10115 7
Delsam Pharma’s NDC 72570-121-15, UPC-72570-0121-15
Delsam Pharma’s Artificial Eye Ointment NDC 72570-122-35, UPC 3 72570 12235 3
Purely Soothing 15% MSM Drops LOT# 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9
All listed Brimonidine Tartrate Ophthalmic Solutions have a strength of 0.15%.
- For the 5mL pack size, the NDC number is 60505-0564-1, and the UPC code on the carton is 360505056415. The UPC code on the bottle is (01)0(03)60505056415. The lot numbers for this pack size are TJ9848, TJ9849, TK0258, and TK5341. The expiry date for lot numbers TJ9848 and TJ9849 is 02/2024, while the expiry date for lot numbers TK0258 and TK5341 is 04/2024.
- For the 10mL pack size, the NDC number is 60505-0564-2, and the UPC code on the carton is 360505056422. The UPC code on the bottle is (01)0(03)60505056422. The lot number for this pack size is TK0261, and the expiry date is 04/2024.
- For the 15mL pack size, the NDC number is 60505-0564-3, and the UPC code on the carton is 360505056439. The UPC code on the bottle is (01)0((03)60505056439. The lot number for this pack size is TK0262, and the expiry date is 04/2024.
If you have used eye drops that match the NDCs and UPCs listed and developed an infection, we urge you to seek legal counsel immediately. These types of FDA recall cases are time-sensitive.
When Do You Need an FDA Recall Lawyer?
It is recommended to speak with an attorney specializing in FDA eye drop recall cases if you or a loved one have experienced bacteria-resistant infections after using EzriCare or Delsam Pharma’s recalled eye drops.
Common symptoms of Pseudomonas aeruginosa infections include:
- Pain or burning sensation in the eyes
- Extreme redness or swelling of the eyes
- Unusual discharge or tear production
- Blurry vision
- Light sensitivity
- Eye infections, such as conjunctivitis or keratitis
Severe infection from contaminated eye drops use include:
- Permanent vision loss
- Permanent vision damage
- Urinary tract infections
- Respiratory infections
- Bloodstream infection
A Pseudomonas aeruginosa bacterial infection can be a serious cause for concern. If you have experienced any adverse events, we urge you to seek medical attention immediately.
Call Today to Schedule a Free Consultation With an FDA Eye Drop Recall Lawyer
If you or someone you care about has suffered harm from using the recalled contaminated eye drops, it’s crucial to take action. Hastings Law Firm specializes in FDA eye drop recall lawsuits and can provide the guidance and support you need to understand your legal options. Mr. Hastings, an experienced attorney in this field, can discuss your case during a free consultation. Don’t hesitate, schedule your appointment today.
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