Americans are being urged to check their medicine cabinets after a major recall involving eye drops and ointments sold under several brands.
Sterling Pharmaceutical Services recalled nearly 750,000 eye care products because of a lack of assurance that they are sterile, according to information reported from the US Food and Drug Administration.
The FDA classified the action as a Class II recall, meaning use could cause temporary or medically reversible health consequences, although the probability of serious consequences is considered remote. People reported the recall on October 3.
Walgreens Products Make Up Most of the Recall
The biggest portion involves Walgreens lubricant eye drops.
Around 301,114 individual bottles of Walgreens Lubricant Eye Drops are affected, along with approximately 199,600 twin packs.
Together, that means more than half a million Walgreens eye drop products are included.
Other Brands Are Affected Too
The recall also covers products distributed under several other names.
They include AvKare lubricant eye drops, Reliable 1 Laboratories products, Cameron Pharmaceuticals lubricant eye drops, TRP Gentle Eyes Lubricant Eye Drops and Major LubriFresh P.M. Nighttime Ointment.
Consumers should check the exact product and lot information rather than assuming only Walgreens products are affected.
Why This Matters
Eye drops must be manufactured under strict sterile conditions because they are applied directly to the eye.
The recall does not mean that every affected bottle is contaminated. The issue is that sterility cannot be adequately assured.
FDA records also show that Sterling Pharmaceutical Services previously received a warning letter after inspectors identified problems involving aseptic processing and environmental controls at its Illinois facility.
What Should You Do?
Anyone who believes they have one of the recalled products should stop using it and contact a healthcare professional, according to the guidance reported with the recall.
Consumers should pay particular attention to symptoms such as eye pain, unusual discharge, persistent redness or changes in vision and seek medical advice if they develop concerning symptoms.
The FDA maintains its current recalls and safety alerts database for consumers who want to check product information.
With hundreds of thousands of products involved, checking any eye drops stored at home could take only a minute and may prevent unnecessary risk.
