[noscript_1]
The FDA has upgraded the recall of more than 2.5 million eye drops issued last month over fears they could be contaminated and cause harm to vision.
Florida-based Lupin Pharmaceutical issued a voluntary recall last month of its prescription-only prednisoLONE Acetate Ophthalmic Suspension one percent eye drops due to an unspecified ‘foreign substance’ being detected in the product.
The alert was issued nationwide for drops sold in five, ten or 15 milliliter white plastic bottles with pink caps.
In the initial alert, the FDA did not classify the threat posed.
But last week, it said this was a Class II recall, the second-highest alert level, indicating ‘a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.’
There have been no reports of illness or deaths due to the drops to date, according to a release on the FDA’s website.
No instructions have been issued for what to do if you have the eye drops, but in previous similar cases, patients have been advised to consult their health provider.
Health officials say that people should not stop using a prescription medication without first contacting their doctor.
The FDA has upgraded its alert level for recalled eye drops
Shown above is the recalled prednisoLONE Acetate Ophthalmic Suspension one percent
Prednisolone eye drops are used in the US to treat allergies, injuries or inflammation in the eye and ease symptoms including swelling, redness and itching.
Prednisolone, a steroid, is also available in inhalers for allergies, in tablets to help ease pain from autoimmune conditions, and in injections to help ease pain in the joints.
Hi, I’m Emma Bardwell, a nutritionist with more than 15 years’ experience helping people improve their health and lose weight.
I’ve been there. I was overweight, unhappy with my skin and stuck in a rut. Then I changed the way I eat. You can now do the same with my tried-and-tested healthy eating plan. And for DailyMail+ subscribers, it’s completely free.
Click here to sign up and start your journey
More than 3.8million prednisolone prescriptions were written in the US last year.
A full list of lot codes of the eye drop bottles that have been recalled is available on the FDA’s website.
The eye drops were made in Pithampur, India and it is not clear how the contamination was detected or what the foreign substance in the eye drops was.
In previous cases, eye drops have been recalled because of contamination with glass, bacteria or fungi. These may enter the products during production.
This follows a major 2023 eye drop recall that was issued for drops made in India after they were found to be laced with a deadly bacteria.
Overall, 81 patients were sickened, while 18 suffered permanent blindness and four died.
The drops were contaminated with the bacteria Pseudomonas aeruginosa, which is resistant to standard antibiotics. It can infect the eye, leading to vision loss and, in extreme cases, it can spread to the blood and trigger the potentially fatal complication sepsis.
And earlier this year in April, more than 3 million eye drops were recalled after inspectors said there was a ‘lack of assurance over sterility’.
The products, made by K.C. Pharmaceuticals, based in California, were sold nationwide in 0.5 fl oz bottles and were on shelves at CVS, Walgreens, Kroger, H-E-B and other stores. The FDA said this was also a Class II recall.
