“This is a contract manufacturing plant that supplies the US market through other factories. This exact drug is not available in India,” the source said. According to the company announcement, the eye drops are distributed by ErziCare and Delsam Pharma.
The drug, used to treat irritation or dry eyes, is available without a prescription. “The product was distributed nationally in the United States via the internet,” according to the company statement.
Pseudomonas aeruginosa Pathogens identified in eye drops
The Centers for Disease Control and Prevention has identified a multi-state cluster of Pseudomonas aeruginosa bacteria resistant to third line carbapenems.
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Unlike in Gambia and Uzbekistan, where Indian officials stopped production after concerns, the Chennai company has recalled the product itself. On the other hand, India’s regulator follows a similar process, with factory inspections conducted immediately after reports are made.
Indian regulators closed factories after similar inspections found businesses in Haryana and Uttar Pradesh not following good manufacturing practices. After that, a risk-based examination of the drug companies was conducted.
In Uzbekistan, 18 toddlers are said to have died of kidney failure after taking two Marion Biotech syrups. In the Gambia, the deaths of 70 children from acute kidney injury were linked to four Maiden Pharma syrups. Impurities—diethylene glycol and ethylene glycol—are thought to be present in both syrups.
FDA warning
The FDA has issued warnings to consumers and doctors to avoid purchasing and using the product. “Using tainted artificial tears increases the risk of eye infections, which can lead to blindness or death,” according to the warning.
The recall was recommended by the FDA due to manufacturing violations such as lack of proper microbiological testing, formulation problems (the corporation manufactures and distributes ophthalmic drugs in adequate multi-use containers). preservation) and lack of appropriate controls regarding evidence of tampering. pack.
Global Pharma Healthcare, based in Chennai, has withdrawn its eye drops from the US market after the Centers for Disease Control and Prevention reported that many patients were experiencing side effects that could be related to the disease. regarding the use of the product. In India, eye drops are not available.
The CDC has informed the FDA that there have been 55 cases of adverse events, including eye infections, irreversible vision loss, and one death from sepsis. CDC is looking into a multi-state outbreak of drug-resistant disease cases linked to the use of ‘Artificial Tears’, lubricating eye drops supplied by EzriCare, LLC and Delsam Pharma in the United States.
The FDA issued a warning on Friday, instructing consumers and doctors not to buy and stop using the product. “Using tainted artificial tears increases the risk of eye infections, which can lead to blindness or death,” according to the warning.
The recall was recommended by the FDA due to manufacturing violations such as lack of proper microbiological testing, formulation problems (the company that manufactures and distributes the eye drops in reusable bottles with insufficient preservatives). management) and lack of appropriate control over evidence of tampering. pack.
While examining an outbreak of an unusually resistant strain Pseudomonas aeruginosa, US agencies have been notified. The group was placed on the US Food and Drug Administration’s import alert list for its inadequate response to a filing request. This warning is intended to prevent the use of the company’s products.
Murali Neelkantan, a former global consultant for Cipla, states that the problem with eye drops or IV fluids is that they are injected into the body and must be manufactured, packaged and distributed in an extremely clean environment. “In another example involving a company whose eye drops were shipped to the UK, investigators discovered contamination in shipping containers containing packaged and sealed eye drops. Although there is no indication that the eye drops are contaminated, the containers are not allowed to enter the market and must be destroyed.”
He goes on to say that quality, especially sterility, needs to be monitored at every stage — before and throughout the manufacturing process, throughout the supply chain, where strict temperature records must be maintained. stored inside containers, at the port of entry and during distribution.
Source: Medindia
