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.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
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.
Compare with the code on your package — it is the most precise check available.
Drug: Gatifloxacin Category: Eye Drops & Ophthalmic
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Labeling: Incorrect or missing package insert.
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Labeling: Missing label; Product complaints reported missing bottle label.
Failed content uniformity specifications.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Presence of Foreign Substance
Presence of particulate matter: a white thread-like structure in the cartridge
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