Chennai-based Global Pharma Healthcare has recalled its eye drops from the U.S. market after U.S. government agency Centers for Disease Control and Prevention said that several people have suffered from adverse events that are possibly associated with the use of the product. The eye drops are not sold in India.
The CDC had alerted the U.S. Food and Drug Administration (FDA) that to date, there were 55 cases of adverse events, including eye infections, permanent loss of vision, and one death with a bloodstream infection. The CDC was investigating a multi-State outbreak of drug-resistant infection cases, which it linked to the use of “Artificial Tears” lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma in the U.S.
A warning issued by the FDA on Friday instructed consumers and doctors to not purchase and stop using the product. “Using contaminated artificial tears increases risks of eye infections that could result in blindness or death,” the warning said.
The FDA had recommended the recall due to manufacturing violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes opthalmic drugs in multi-use bottles, without adequate preservatives), and lack of proper controls concerning tamper-evident packaging.
The U.S. agencies were alerted while investigating an outbreak of a rare, drug-resistant strain of Pseudomonas aeruginosa bacteria. The company has been placed on the U.S. FDA’s import alert list for an inadequate response to a records request. This alert is aimed at preventing the company’s products from entering the U.S.
Former global counsel of Cipla, Murali Neelkantan, said that the challenge with eye drops or IV fluids is that they are administered inside the body and they should be manufactured, packed and shipped in highly sterile environments. “In another case of a company whose eye drops were to be supplied to the U.K., officials found contamination in shipping containers that contained the sealed and packaged eye drops. The containers were not allowed to enter the market and had to be destroyed even though there was no evidence that the eye drops were contaminated.”
He added that quality, especially sterility, needed to be checked at each step — before and during manufacture, through the supply chain where strict temperature logs should be maintained inside the containers, at the port of entry and while being dispensed.
(With PTI inputs)