February 2023

A recent outbreak of eye infections is raising concern as the Centers for Disease Control and Prevention (CDC) investigates 56 cases from 12 states.

All appear to have arisen from the use of a popular eye drop that became contaminated with Pseudomonas aeruginosa.

The strain, which is extensively antibiotic-resistant, including to carbapenems, has not been identified in the country prior to this outbreak. At least one death and five cases of vision loss have been linked to the use of the product. Both the CDC and the FDA advise people to stop using the eye drops as the investigation continues.

The product is marketed as being “preservative free” and is distributed from a multiuse bottle. According to their announcement, the “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 outbreak highlights the importance of proper formulation of personal care products with effective preservatives, determining the best possible packaging option, and conducting batch-by-batch testing to detect the presence of dangerous pathogens,