FDA recall D-0924-2023

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.

Reason for recall

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2023-07-05

Report date

2023-07-26

Termination date

2024-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0924-2023