Maker of eye drops linked to deadly outbreak flunks FDA inspection
Enlarge (credit: Getty | DEA / M. FERMARIELLO/De Agostini )
The maker of eye drops linked to a deadly outbreak of extensively drug-resistant infections in the US had a slew of manufacturing violations-from brown slime on filling equipment to a lack of basic measures and systems to ensure sterility-according to an inspection report released by the Food and Drug Administration (PDF).
In February, the regulator warned consumers to immediately stop using eye drops and eye ointment made by Global Pharma, whose products were sold in the US under brand names EzriCare and Delsam Pharma and were available through Amazon, Walmart, eBay, and other retailers. Global Pharma later issued voluntary recalls of the products.
Health investigators had linked the drops to cases of an extensively drug-resistant Pseudomonas aeruginosa strain that had never been seen before in the US. The strain is identified as VIM-GES-CRPA, which stands for a carbapenem-resistant P. aeruginosa (CRPA) with Verona integron-mediated metallo--lactamase (VIM) and Guiana extended-spectrum--lactamase (GES). Although affected people reported using multiple brands of eye drops, EzriCare was the most common. Additionally, testing by the Centers for Disease Control and Prevention and independent researchers have identified the outbreak strain in opened bottles of EzriCare artificial tears.