Kilitch Healthcare India is recalling 27 eye drops from its product lines sold nationwide at CVS, Target, Walmart, and other pharmacies due to improper sterilization, the FDA said on Nov. 15.
Generic store brands like Equate sold at Walmart, and lubricating eye drops sold under the Rugby brand are all made in India by Kilitch. The recall was voluntary. The company told the FDA that it has not received any reports of adverse reactions related to these products yet. Improperly sterilized drops come with the risk of eye infection and other harms. These products are intended to be sterile because drugs applied to the eyes bypass some of the body’s natural defenses.
The full list of products recalled by Kilitch can be found here on the FDA’s website.
India’s imported eye drops have become infamous.
In April, the EzriCare brand recalled eye drops that led to severe eye damage, and even blindness due to bacterial infection. NBC News reported on three patients dying because of it.
The Center for Disease Control alerted the public to the potential danger in a statement on Jan. 20. But physicians across the country had been reporting cases of the new bacterial infections since the summer of 2022.
The FDA released a preliminary report from an inspection at EzriCare’s Global Pharma Healthcare facility in India, finding problems with the manufacturing process and the factory’s measures to assure sterility. Most of the infections were not caught until they were advanced.
In October, Cardinal Health recalled six eye drop products sold under the Leader brand, all made in India.
Generic medicines account for roughly 90 percent of all prescriptions dispensed in the U.S., and 100 percent of over-the-counter drugs not requiring a doctor’s visit. Unfortunately, the U.S. is almost fully reliant on imports for generic drugs. And their quality often depends on the labs admitting any mistakes and recalling their medications from the market swiftly before any harm is done.
Bloomberg opinion writer Ruth Pollard actually went so far as to write in a column on April 4 that India’s generic drugs were “very dangerous”.
For a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight. In the last six months alone, its generic cough syrups have killed dozens of children, its eye drops have caused blindness and its chemotherapy drugs have been contaminated. The children who died — mostly under the age of five years — were given Indian-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts. The eye drops that contained extensively drug-resistant bacteria? So far 68 patients across 16 US states have been affected. Three people died, several had to have their eyeballs removed. – Ruth Pollard, “Just How Dangerous Are India’s Generic Drugs? Very.” Bloomberg Opinion, April 4, 2023.
On Oct. 26, Rep. Claudia Tenney (R-NY-24) introduced legislation that would help fund generic drug production in the United States, similar to what Biden signed into law with the CHIPS & Science Act, and the Inflation Reduction Act.
CPA supports this legislation.
“In recent years, drug manufacturing has shifted away from the United States, threatening American jobs and the security of our vital medicine supply chains,” said Congresswoman Tenney. “To bolster domestic generic medicine production and guard against future supply chain disruptions, I introduced the PILLS Act to incentivize businesses to produce these important pharmaceutical products in the United States. This legislation is a crucial step to not only re-shore drug production, but also to strengthen our domestic supply chains and create American manufacturing jobs.”