STAT+: Delay of eye drop recall highlights FDA’s impotence on the issue
It took the FDA a while to coax companies to take certain eye drops off shelves. Key lawmakers say the agency must be able to force recalls.
WASHINGTON — It took nearly three weeks for a maker of eye drops to recall its products after the Food and Drug Administration requested a recall. There have been no reports of injuries, but some key lawmakers are arguing the time it took the FDA to coax a voluntary recall shows the agency should be given the power to force them.
Eye drops must be sterile because drugs applied to eyes bypass some of the body’s natural defenses.
FDA inspectors found unsanitary conditions at a facility in India that makes over-the-counter eye drop products that multiple U.S. retailers and distributors sell under their own brand names. Those brand names include CVS Health, Rite Aid, Target’s Up & Up.
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