Global Pharma Healthcare Recalls Artificial Tears Due to Contamination
After the CDC identified bacterial infections, the FDA announced that Global Pharma Healthcare had voluntarily recalled its artificial tears due to contamination by Pseudomonas aeruginosa.
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- Global Pharma Healthcare has voluntarily recalled multiple batches of artificial tears after patients experienced severe side effects, such as vision loss and mortality. On January 31, 2023, the CDC reported that 55 patients across 12 states had Pseudomonas aeruginosa infections, resulting in five cases of vision loss and one death.
According to the CDC, most of the patient population was linked to four clusters of healthcare facilities. Patient infections were identified between May 2022 and January 2023 through various testing methods, including but not limited to blood tests, urine tests, and phlegm cultures. The testing identified a dangerous and rare version of Pseudomonas aeruginosa, VIM-GES-CRPA, a drug-resistant bacteria.
Efforts to identify the origin of this bacterial infection determined that most patients had used artificial eye drops. While the brands varied, the most common brand used was Ezricare Artificial Tears, a supposedly preservative-free, over-the-counter version of lubricating eye drops.
The CDC conducted additional testing, determining that the bacteria was present in open bottles of Ezricare Artificial Tears from two states. Patients using this bottle had not reported eye infections, implying that it was not an existing bacterial infection from the patient that contaminated the bottle. However, the CDC is still in the process of testing unopened bottles.
The recall applies to lubricant eye drops by Ezricare and Deslam Pharma. The announcement notes, “The product is packaged in a bottle with a safety seal and is placed in a carton box: Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC -72570-0121-15.”
In an announcement separate from the recall, the FDA notes that the recall, while voluntary, was recommended due to violations of current good manufacturing practices. These violations included insufficient microbial testing, inadequate preservatives, and improper control of tamper-evident packaging.
According to the FDA press release, “FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. The import alert prevents these products from entering the United States.”
Patients using these products are advised to discontinue use and contact a healthcare provider immediately if they are experiencing symptoms of an eye infection, including discharge from the eye, eye pain or discomfort, eye or eyelid redness, foreign body sensation, sensitivity to light, dry eyes, and blurred vision.
