Product: LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated: 20210315
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated