Global Pharma Healthcare Recalls Eye Drops Due to Bacterial Outbreak
Global Pharma Healthcare is issuing a recall on EzriCare Artificial Tears Lubricant Eye Drops, Delsam Pharma Artificial Tears Lubricant Eye Drop, and more recently Delsam Pharma Artificial Eye Ointment due to potential bacterial contamination.
About the Global Pharma Healthcare Recall
There has been a concerning outbreak of Pseudomonas aeruginosa bacteria linked to the artificial tear products.
In response to this serious issue, the FDA has recommended a recall of these products due to significant violations of FDA protocols. These violations include the lack of proper sterilization of multi-use bottles, inadequate testing for bacterial contamination, and packaging the artificial tears without sufficient preservatives.
As of the latest update from the CDC (Centers for Disease Control and Prevention), the outbreak has affected over 68 people in the United States. Some individuals have experienced vision loss or required surgical removal of their eyeball, and there has been one reported fatality.
It is crucial for consumers of these products to immediately discontinue their use and safely dispose of them. Additionally, the CDC advises consumers to be vigilant for potential symptoms of infection. Should you experience any concerning symptoms, it is essential to seek immediate medical attention from a local healthcare provider.
Details of the Eye Drop Recall
The following information was provided by Consumer Reports:
The Recall All unexpired preservative-free artificial tear products sold under the brand names EzriCare Artificial Tears Lubricant Eye Drops and Delsam Pharma Artificial Tears Lubricant Eye Drops. Labels on product boxes will include the following codes:
- UPC 3 79503 10115 7
- NDC 79503-0101-15
- Delsam Pharma:
- UPC 3 72570 12115 8
- NDC 72570-121-15
Additionally, be cautious of all products under the name Delsam Pharma Artificial Eye Ointment (NDC 72570-122-35, UPC 3 72570 12235 3).
The Risk: The products mentioned above may be contaminated with a dangerous drug-resistant bacteria, Pseudomonas aeruginosa, which can lead to severe illnesses, blindness, and even death.
Incidents/Injuries: A bacterial outbreak has resulted in 55 reports of illness and one confirmed death.
Sale Details: The recall alert does not specify the exact period of sale for these products. However, recorded illnesses have occurred between May 2022 and January 2023. The affected eye drops were distributed and sold online throughout the entire nation.
The Remedy: If you possess any of these products, it is crucial to discontinue their use immediately. Should you experience any symptoms or health concerns, please seek immediate assistance from a healthcare provider.
Report Adverse Events: Should you encounter any adverse effects related to these products, please promptly report them to the FDA for further investigation and monitoring. Your cooperation is essential in safeguarding public health and preventing further incidents.