FDA Inspection Reveals Sterilization Issues at Eye Drop Manufacturer Linked to Bacterial Outbreak and Deaths.
The FDA has inspected the India-based manufacturer of EzriCare artificial tears, Global Pharma Healthcare, after three deaths and multiple cases of blindness were linked to the company's eye drops contaminated with a highly drug-resistant bacteria. The inspection revealed dozens of problems, including surfaces that weren't sterilized and ingredient verification checks that weren't conducted. The FDA has extended the warning to a second eye product manufactured by Global Pharma, Delsam Pharma's Artificial Eye Ointment. All of the company's eye drops have been recalled, and the strain behind the outbreak, an extremely drug-resistant Pseudomonas aeruginosa, has never been reported in the US.
- Eye Drops Recall: Deaths, Blindness, Now an FDA Inspection Newser
- Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person The New York Times
- Eye drops recall: FDA finds dirty equipment at manufacturer linked to bacterial outbreak in EzriCare, Delsam Pharma products CBS News
- 'Drug-Resistant' Bacteria Leads To Death, Blindness In New York Hudson Valley Post
- FDA inspection finds sterilization issues at recalled eye drop manufacturer's facility CNN
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