FDA discovers sterilization and contamination issues at Global Health Pharma's eye drop facility.
The FDA found that Global Pharma Healthcare did not follow proper sterilization or cleaning procedures at its manufacturing facility, leading to the recall of its eye drops due to potential microbial contamination. Nearly 70 patients in 16 states have been infected with a "rare strain" of Pseudomonas aeruginosa, and three people have died from infections. The FDA's inspection report revealed that the company "used a manufacturing process that lacked assurance of product sterility" and "lacked a clear and specific written procedure for aseptic interventions performed." Patients who have used the recalled products and are showing signs or symptoms of an eye infection should seek medical help immediately.