Global Pharma Healthcare is issuing a voluntary nationwide recall of all lots within the expiry of their Artificial Tears Lubricant Eye Drops. The consumer-level recall is carried out due to possible contamination of the products distributed by /EzriCare, LLC- and Delsam Pharma.
This recall was initiated after the Center for Disease Control and Prevention (CDC) investigated 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 which they believed to be associated with the use of artificial tears eye drops from Global Pharma Healthcare.
To Date, Global Pharma Healthcare has received up to 55 reports of eye infections, permanent vision loss, and death resulting from bloodstream infection.
Risk Statement
The use of this contaminated artificial tear drop can result in eye infections which can lead to permanent blindness.
The Artificial Tears Lubricant Eye Drops packed in 10 mg in 1 mL, ½ fl oz (15 ml) bottle is indicated for use in protection against eye irritation and relief of dry eyes.
It is used to temporarily relieve eye discomfort, minor irritation or exposure to sun and wind. Consumers can identify these products with their safety seals which are then placed in cartons Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC 3 72570 12115 8. The products were distributed online throughout the US.
Global Pharma Healthcare is notifying its distributors, Aru Pharma Inc., and Delsam Pharma, about the recall and warning them to stop further distribution of the affected products.
Wholesalers and retailers are also urged not to distribute the products any further. Consumers who have these products should stop using them immediately.
Consumers are advised to contact the distributors if they have any questions regarding the recall. They can reach Aru Pharma/Ezricare, LLC by phone: at 1-516-715-5181 from Monday to Friday, 11 am to 4 pm EST or by e-mail at: [email protected]. DELSAM Pharma LLC can be reached by phone at 1-866-826-1306 Monday to Friday from 11 am to 4 pm EST or by email [email protected].
Consumers can also talk to their healthcare providers if they experience any side effects that may be associated with the use of the artificial teardrop, which is usually sold over the counter.
Adverse reactions to quality issues can be reported to the FDAs MedWatch Adverse Event Reporting program through the following means:
- Complete and submit the report online.
- Regular Mail or Fax: Download the form or call 1- 800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The recall is conducted with full knowledge of the FDA.
