FDA-Drug2023-07-26Class III
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.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Sold states
USA nationwide.
Affected count
20,884 cartons
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0924-2023Don't want to check this manually?
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