Lupin Pharmaceuticals Inc. is recalling 50,832 bottles of Gatifloxacin Ophthalmic Solution, 0.5% (2.5 mL). This voluntary recall was issued after testing revealed water loss in some bottles, which could increase the concentration of the medication. No incidents or injuries related to this issue have been reported to date.
A higher concentration of the medication than intended may cause the eye drops to work improperly or cause irritation. Using medication that does not meet stability specifications could lead to unexpected side effects or reduced effectiveness of the treatment.
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Manufactured by Lupin Limited, Pithampur, India.
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Sources: FDA iRES · Raw API Response
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