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FDA faults company behind recalled eye drops for multiple violations, bans imports

FDA faults company behind recalled eye drops for multiple violations, bans imports

CBSN
Friday, February 03, 2023 03:12:46 AM UTC

The Food and Drug Administration announced Thursday that it has moved to restrict imports of products manufactured by an Indian healthcare firm, after it urged the company to recall eye drops linked to an outbreak of "extensively drug-resistant" bacteria across the country.

Global Pharma Healthcare Private Limited produces artificial tears that are sold under the brand names EzriCare or Delsam Pharma, which are now all being recalled. 

The FDA cited multiple violations of manufacturing regulations by the company, including a "lack of appropriate microbial testing" and a "lack of proper controls concerning tamper-evident packaging."

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