Class II · Moderate risk Terminated
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
What was recalled
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 62756-232-55
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0924-2023
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.
Other Loteprednol recalls
See all
Class III · Low risk Terminated
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant…
Reason Failed Stability Specifications: Out of specification for viscosity.
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