The FDA expanded its recall for eye drops potentially contaminated with a highly drug-resistant bacteria that has hospitalized 16 and blinded six patients, CBS News reported Feb. 22.
The FDA has added Delsam Pharma's Artificial Eye Ointment to the recall of over-the-counter products manufactured by Global Pharma Healthcare Private Limited. This is the third product recalled by this manufacturer linked to the bacterial infection. The FDA faulted the company for multiple violations and banned imports of its items into the U.S.
It is unclear why the FDA expanded the recall. A spokesperson declined to provide additional details on the "ongoing matter."
This strain of Pseudomonas aeruginosa has not been identified in the U.S. before. The CDC found the bacteria in opened bottles of EzriCare and is testing unopened bottles. So far, unopened bottles have shown no signs of contamination, according to the report, but additional bottles are being tested.
Here are three updates:
- So far, the CDC has reported 58 patients affected by the infection across 13 states.
- Illinois recently became the 13th state to report an infection.
- At least 16 people have been hospitalized. Five were permanently blinded, and one had an eyeball surgically removed, the CDC told CBS News. Only one patient has died after the infection spread to their bloodstream.