Lupin Pharmaceuticals Inc. has recalled approximately 2,130 bottles of Bimatoprost Ophthalmic Solution (0.03%), a prescription eye drop medication used to treat certain eye conditions. The recall was initiated because routine testing discovered an impurity that was outside of approved safety specifications, which may affect the product's quality and performance. The affected medication is packaged in 7.5 mL sterile bottles and was distributed nationwide in the United States.
The presence of unknown impurities or degradation products in a sterile ophthalmic solution can lead to reduced drug effectiveness or potential irritation to the sensitive tissues of the eye.
Drug recall guidance for consumers and patients.
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Sources: FDA iRES · Raw API Response
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