National pharmacy chains in October were among a host of outlets to remove dozens of eyecare products from their shelves due to potential contamination concerns.
Now the Indian company behind those products, Kilitch Healthcare, has officially issued a voluntary recall of 27 brands and formulations of lubricating eyedrops.
The move came after the U.S. Food and Drug Administration recently toured the Kilitch Healthcare India manufacturing facility in Mumbia where the products were produced. U.S. health inspectors uncovered a host of sanitation and manufacturing problems during their visit. Among the issues documented were barefoot workers, altered records, and cracked floors.
According to a story by The Associated Press, an FDA report on the facility included “factory workers not wearing masks, gloves and gowns and working barefoot in areas that are supposed to be sterile. A manager told FDA officials ‘that this is their standard practice.’”
The FDA also uncovered evidence that factory officials falsified contaminated test results or outright omitted results on a routine basis. A microbiologist who works at the facility said erroneous reporting of sterility tests happed, “two or three times per month.”
Eyedrops from the factory were sold at CVS Health, Walgreens, Rite-Aid, Walmart, and Target, among others. A full list of effected products is available here.
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From the FDA
For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.
FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at Medwatch; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
