Akorn, Inc. is recalling approximately 149,159 bottles of Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (5 mL), a prescription antibiotic eye drop used to treat bacterial eye infections. Crystalline particles were discovered in the solution during 24-month clarity testing, indicating the product may not be stable through its full shelf life. Consumers using these affected lots may be at risk of eye irritation or injury from the particulate matter.
The presence of crystalline particles in an ophthalmic solution can cause physical irritation, redness, or more serious abrasive damage to the delicate tissues of the eye when the drops are administered. No specific injuries have been reported in the provided data, but the presence of solids in a solution intended to be clear poses a safety risk to the user.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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