FDA, EzriCare와 Delsam Pharma의 인공 눈물 리콜

The Food and Drug Administration (FDA) warned consumers and health care practitioners in early February 2023, not to purchase and to immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using these contaminated products increases risk of eye infections that could result in blindness or death.

Later in the month, the FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment, and the firm agreed to initiate a recall of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. The FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.

If you have been injured by Ezricare of Delsam Pharma’s Artificial tears, contact an attorney today.