Sun Pharmaceutical Industries Inc. has voluntarily recalled approximately 20,884 cartons of Loteprednol Etabonate Ophthalmic Suspension (0.5%), an eye medication used to treat certain inflammatory conditions. The recall was initiated because the drug was found to be superpotent, meaning it contains a higher concentration of the active ingredient than is specified on the label. This issue was discovered during testing of the unit dose content, and no injuries or incidents have been reported to date.
A superpotent ophthalmic suspension contains more medication than intended. Using a superpotent drug can lead to unexpected side effects or adverse reactions in patients, as the concentration of the active ingredient exceeds safe and tested limits.
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Recall #: D-0924-2023. Packaged as one bottle in a carton.
Recall #: D-0924-2023. Packaged as one bottle in a carton.
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Sources: FDA iRES · Raw API Response
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