The manufacturer of eye drops linked to antibiotic-resistant infections did not meet proper sanitary safety and quality assurance measures, according to a preliminary inspection report from the Food and Drug Administration (FDA).
The eye drops were recalled in February. Health inspectors found 11 problems at Global Pharma Healthcare’s manufacturing site in Tamilnadu, India. Observations made during an 11-day inspection beginning in late February included:
- “Black, brown colored greasy deposit” on a bowl used to transfer bottles
- “Deficient” processing areas for cleaning and disinfecting the room
- Floors, walls and ceilings were not “easily cleanable”
- Container closures were “not cleaned, sanitized, decontaminated or sterilized”
- A lack of written procedures for cleaning or maintaining equipment
The eye drops were sold in the U.S. under the brands EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. They caused 81 known bacterial infections, leading to four deaths, 14 cases of vision loss and eight individuals who required surgical removal of their eyeball because of the infection, the Centers for Disease Control and Prevention (CDC) said.
The type of infection linked to the drops, Pseudomonas aeruginosa, is resistant to antibiotics and poses a greater threat to those who are immunocompromised. CDC testing determined the bacteria in the recalled products was resistant to antibiotics such as carbapenem, ceftazidime and cefepime.
Although most infections were linked to the EzriCare brand of eye drops, patients with infections reported using more than 10 different brands of artificial tears.
Though preservative-free drops are recommended for people who apply artificial tears more than four times a day or have moderate to severe dry eyes, they are more likely to support bacterial growth after the bottle is opened, according to the Mayo Clinic.
According to the CDC, signs of an eye infection include:
- Discharge from the eye
- Pain or discomfort
- Sensitivity to light
- Blurry vision
- A feeling like something is in the eye