Mylan Pharmaceuticals Inc. has recalled approximately 13,157 bottles of Gatifloxacin Ophthalmic Solution 0.5% (2.5 mL per bottle), a prescription eye drop used to treat bacterial infections. This recall was initiated because the product failed quality specifications due to the presence of an unknown impurity or degradation. Consumers who use this medication should be aware that the product does not meet the necessary safety and purity standards required for medical use.
The presence of unknown impurities or degradation products in an ophthalmic solution can cause irritation or reduced effectiveness of the medication. Using a contaminated or degraded eye drop increases the risk of adverse reactions or potential injury to the eye.
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Sources: FDA iRES · Raw API Response
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