Feb. 22, 2023 — Don’t buy or use Delsam Pharma’s Synthetic Eye Ointment, the FDA warns.
The announcement launched Wednesday provides to a earlier warning issued earlier this month for EzriCare Synthetic Tears or Delsam Pharma’s Synthetic Tears attributable to potential bacterial contamination. All three merchandise are manufactured by the identical firm, International Pharma Healthcare, primarily based in Tamilnadu, India.
The FDA has faulted the corporate for a number of violations, together with “lack of acceptable microbial testing” and “lack of correct controls regarding tamper-evident packaging,” and has banned imports to the USA.
The up to date warning from the FDA didn’t give extra details about the over-the-counter eye ointment past potential bacterial contamination.
On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant pressure of micro organism, Pseudomonas aeruginosa, linked to synthetic tear merchandise. So far, 58 sufferers throughout 13 states have been recognized, and probably the most generally reported synthetic tear model was EzriCare Synthetic Tears. 5 sufferers had everlasting imaginative and prescient loss, and one affected person died.