Tamil Nadu’s drug controller instructed Chennai-based Global Pharma Healthcare to suspend production of its ophthalmic products on February 4, 2023, while officials investigated eye drops linked to a U.S. drug-resistant infection outbreak. The order covered eye medicines, not all of the company’s manufacturing. CDC had found the outbreak strain in opened EzriCare Artificial Tears bottles, but said that finding alone could not establish whether contamination happened during use or during manufacturing.
What Tamil Nadu ordered—and what the order covered
On February 4, 2023, Tamil Nadu’s drug controller told Global Pharma Healthcare to stop manufacturing ophthalmic products until the investigation was completed. A joint central and state inspection had taken place on February 3. Officials collected retained control samples of finished eye drops and samples of the raw material used to make them. The state drug controller told Scroll that the ophthalmic manufacturing unit was separate from the company’s other product categories, and said, “We have only suspended manufacturing activities for ophthalmic products for now.”
The instruction was a precautionary regulatory action during an investigation, not a finding that the manufacturing site had caused the outbreak. The sources available establish the initial suspension and a later reported sample result, but do not establish the suspension’s complete final disposition. It should not be described as still in effect or formally lifted without newer authoritative evidence.
What the CDC alert said about the outbreak
The Centers for Disease Control and Prevention issued its Health Alert Network advisory on February 1, 2023. As of January 31, CDC and state and local health departments had identified 55 case-patients in 12 states with VIM-GES-CRPA, an extensively drug-resistant strain of Pseudomonas aeruginosa. CDC reported permanent vision loss, hospitalizations and one death from systemic infection. Those numbers describe the advisory’s dated snapshot, not final outbreak totals.
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Most patients who had used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product sold in multidose bottles. CDC testing found the outbreak strain in opened EzriCare bottles with different lot numbers collected in two states; isolates from the product matched the outbreak strain. This linked the opened product samples to the outbreak investigation, but did not resolve how the bottles became contaminated.
Why opened-bottle findings did not prove a manufacturing source
An opened bottle may have been contaminated during manufacturing or after opening, through use or handling. CDC explicitly noted both possibilities and said testing of unopened bottles was ongoing to assess whether manufacturing contamination may have occurred. Its findings in opened bottles therefore did not, by themselves, prove that Global Pharma’s manufacturing process caused the outbreak.
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There are two distinct pieces of evidence to keep separate:
- CDC’s outbreak investigation: the outbreak strain was detected in opened EzriCare bottles, and product isolates matched the strain found in patients.
- The unresolved source question: because those bottles had been opened, the result alone could not distinguish contamination during use from contamination during manufacturing.
What the later Indian sample result reported
In an April 4, 2023 report, NDTV attributed to Tamil Nadu drug-control director P.V. Vijayalakshmi the statement that samples from unopened bottles, including the batch under question, showed no contamination and that raw materials met standards. This was a later reported result from domestic testing, not a CDC finding.
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The two results concern different samples and investigations: CDC reported finding the outbreak strain in opened bottles, while the Tamil Nadu result reported by NDTV concerned unopened bottles and raw materials. The latter does not erase CDC’s earlier finding, and the opened-bottle finding does not establish that unopened bottles from the tested batch were contaminated.
Which products were involved, and where they were sold
Global Pharma announced a voluntary recall of its Artificial Tears lubricant eye drops in the United States after the FDA informed the company of adverse-event reports. Contemporaneous reporting associated the products with the EzriCare Artificial Tears and Delsam Pharma Artificial Tears labels. A Delsam representative disputed that its product was included in CDC complaints; that was the distributor’s statement, not an independently established conclusion.
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Reports at the time said the products were exported to the United States and were not sold in India. That describes contemporaneous reporting, not a guarantee about current distribution.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What CDC advised consumers to do
In its February 1, 2023 advisory, CDC recommended: “Discontinue using EzriCare Artificial Tears pending additional guidance from CDC and FDA.” It also advised people with signs or symptoms of an eye infection after using the product to seek timely medical care. CDC did not recommend testing people who had no symptoms. Anyone whose healthcare provider had recommended EzriCare was advised to contact that provider about an alternative artificial tears product.
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