The FDA warned consumers to stop using eyedrop products from six different brands on Wednesday after agency investigators found bacteria contamination at a manufacturing site.
Manuel Balce Ceneta/AP
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Manuel Balce Ceneta/AP
The FDA warned consumers to stop using eyedrop products from six different brands on Wednesday after agency investigators found bacteria contamination at a manufacturing site.
Manuel Balce Ceneta/AP
U.S. health officials are warning consumers to stop using more than two dozen over-the-counter eye drop products due to the potential risk of eye infection that could lead to vision loss.
The Food and Drug Administration on Friday issued the alert for 26 products from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma.
The federal regulatory agency said it recommended the manufacturers to recall of the subject products on Wednesday, after FDA investigators found bacterial contamination in critical drug production areas of a manufacturing facility.
CVS, Rite Aid and Target are removing the products in store and online, according to the FDA. Products branded as Leader, Rugby and Velocity may still be available but should not be purchased, said the agency. None of the products have caused adverse effects in consumers yet, they added.
It’s the FDA’s latest statements in a series of warnings against using eyedrop products linked to potential contamination. Two months ago, the FDA urged consumers to stop using two eyedrop products due to bacterial and fungal contamination. At the time, the drug-resistant bacteria Pseudomanas aeruginosa, Mycobacterium, Mycolicibacterium and Methylorubrum was found in LightEyez MSM Eye Drops Eye Repair product; Dr. Berne’s MSM Drops 5% Solution was contaminated with Exophiala fungi.
In February, the Centers for Disease Control and Prevention reported an outbreak of Pseudomonas aeruginosa tied to the contamination of other brands of artificial tears and eyedrops.
As NPR previously reported, the bacteria strain was found in 81 people, four of whom had died from infections, the CDC said in May.
Over 10 different brands were linked to the infections, the most common being Ezri Care Artificial Tears from India-based Global Pharma Healthcare. The FDA said Global Pharma’s microbial testing of its eye product was inadequate and that the pharmaceutical provider failed to use adequate, tamper-resistant packaging and distributed the drugs without proper preservatives.
Two additional companies recalled eyedrop products in February, although those products were not linked to the infections at the time.
In its Friday notice, the FDA did not specify the bacteria strain that was found at the manufacturing site.
