FDA-Drug2021-06-02Class II

LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
463 boxes
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0443-2021

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