Eye drops linked to a nationwide bacterial outbreak have been recalled after the Centers for Disease Control and Prevention identified the drops as a source of the infections.
Indian pharmaceutical manufacturer Global Pharma Healthcare recalled the eye drops, sold under the EzriCare and Delsam Pharma brand names, because they may be contaminated with an antibiotic-resistant strain of bacteria.
The outbreak has infected at least 55 patients in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin.
One person has died from a bloodstream infection after using the drops, while others were permanently blinded, according to the CDC.
The CDC identified multi-dose, preservative-free EzriCare bottles as a source of the outbreak in a Jan. 20 report. Because the drops are preservative-free, they don’t have ingredients to prevent the growth of dangerous bacteria.
The two products being recalled are 15-milliliter bottles, branded for EzriCare and Delsam Pharma. The EzriCare box has the national drug code 79503-0101-15. The Delsam Pharma box has the national drug code 72570-121-15.
Both products were distributed across the U.S. through the Internet.
The Food and Drug Administration issued an import ban on Global Pharma due to “an inadequate response to a records request and for not complying with [current good manufacturing practice] requirements,” the agency wrote in an alert.
Those violations include a lack of adequate microbial testing and distributing medicine in multi-use bottles without preservatives.
After making an initial statement on Jan. 24, EzriCare put out an update to consumers on Wednesday explaining its role in the manufacture and sale of the eye drops.
“EzriCare LLC’s only role in introducing the product to the market was to design an exterior label and to market it to our customers. EzriCare LLC had no role in the formulation, packaging delivery system design or actual manufacturing of this product,” the company wrote.
• Brad Matthews can be reached at bmatthews@washingtontimes.com.