A company has voluntarily recalled its eye drops due to possible microbial contamination. They may be linked to more than 50 cases of adverse events.
Global Pharma Healthcare’s recall affects “all lots within expiry” of its EzriCare and Delsam Pharma artificial tears lubricant eye drops, according to the U.S. Food and Drug Administration (FDA).
Health authorities have identified “extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states.” The infections may be linked to the use of the product.
As of Jan. 31, there were 55 reports of adverse events, with cases identified in a dozen states including California, New Jersey and Texas. It includes reports of “eye infections, permanent loss of vision, and a death with a bloodstream infection.”
According to a health alert from the Centers for Disease Control and Prevention (CDC) on Wednesday, “most” of the patients reported using artificial tears before they got the infection. Ten different brands were used, while some even used multiple brands. However, the “majority” of them reportedly used EzriCare artificial tears.
“CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states,” the FDA noted, adding that it is working to identify whether the contamination happened during manufacturing or use. Testing of unopened bottles would help figure that out.
In a separate statement, Ezricare said it was “not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears.” It also clarified its “only role” was in designing the exterior label and marketing and that it played “no role in the formulation, packaging delivery system design or actual manufacturing of this product.”
“Nonetheless, we immediately took action to stop any further distribution or sale of EzriCare Artificial Tears,” EzriCare wrote. “To the greatest extent possible, we have been contacting customers to advise them against continued use of the product.”
The recalled products were packed in carton boxes with the codes 79503-0101-15 (Ezricare-NDC), 3 79503 10115 7 (Ezricare-UPC), 72570-121-15 (Delsam Pharma-NDC) and 72570-0121-15 (Delsam Pharma-UPC). They were distributed nationwide, as well as online.
Sample photos and more information about the recall are available on the FDA website. Those with questions can contact Aru Pharma/Ezricare at 1-518-738-7602 or the distributor Delsam Pharma at 1-866-826-1309 .
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