SUN PHARMACEUTICAL INDUSTRIES INC recalls Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#
Recalled July 26, 2023 · FDA recall D-0924-2023 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. · FDA Class III
Units
20,884 cartons
Sold at
USA nationwide.
Description
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Product
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.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →