2-03-2023 7:44am

Artificial Tears Lubricant Eye Drops by Global Pharma Recall

Anita Johnson-Brown Editor

On February 2, 2023, FDA Med Watch announced the recall of Global Pharma Healthcare of all lots within the expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, due to possible contamination.

The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare.

To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and death with a bloodstream infection.

Risk Statement: The use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

RECOMMENDATIONS:

Consumers and patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.
Consumers and patients with questions regarding this recall can contact the company.
Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop use.
For more information read the related information:
- Drug Safety and Availability – 02-02-2023
- CDC Health Alert Network – 02-01-2023

Consumers, patients, and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the form, or submit it by fax to 1-800-FDA-0178.

click on the red button "Read Recall" below for more information about this recall