Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug…
Reason Labeling: Incorrect or missing package insert.
Reason Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Reason Labeling: Missing label; Product complaints reported missing bottle label.
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