In early 2023, Global Pharma Healthcare voluntarily recalled several eye drop products due to reports of a rare strain of bacterial contamination.
Weeks later, the US Food and Drug Administration (FDA) put out an official warning concerning the Global Pharma Healthcare voluntary recall.
The additional guidance published by the FDA also touched on quality problems associated with Global Pharma Healthcare products, stating the following:
“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.”
The FDA also issued an import alert on Global Pharma products for the company’s inadequate response to a records request and for not complying with CGMP requirements.
In April 2023, it was reported that the FDA found dozens of issues at the factory where the contaminated eye drops were produced.
What Type of Bacterial Contamination is Present in EzriCare Artificial Tears?
The Centers for Disease Control and Prevention (CDC) identified that EzriCare Artificial Tears and other products may contain carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA)
Carbapenem resistant Pseudomonas aeruginosa (CRPA) is an extensively drug resistant strain of bacteria.
The Centers for Disease Control and Prevention (CDC) also said that this is the first time this rare strain has been reported in the United States.
