Alembic Pharmaceuticals Limited has voluntarily recalled three lots of Bromfenac Ophthalmic Solution 0.09%, a sterile prescription eye drop (1.7 mL bottle). The recall was issued because the product failed to meet established specifications for impurities or degradation during testing. Using medication that has degraded or contains higher-than-allowed impurity levels may result in reduced effectiveness or unintended reactions in the eye.
Patients using these eye drops may be exposed to chemical impurities or degradation products that could cause irritation or fail to properly manage inflammation following cataract surgery. No specific injuries or adverse events have been reported to date.
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Manufactured for Alembic Pharmaceuticals, Inc., Bedminster, NJ; Manufactured by Alembic Pharmaceuticals Limited, Gujarat, India.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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