Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Stability Specifications: Out of specification for viscosity.
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
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 Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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