Loteprednol Etabonate Ophthalmic Suspension…

Date

July 26, 2023

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

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

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

Distribution pattern

USA nationwide.

Quantity

20,884 cartons

Codes and lots

Lot#: a) BAC0334A, Exp 06/2023; BAC0532A, Exp 11/2023 BAD0407A, Exp 08/2024 BAD0425A, Exp 08/2024; b) BAC0335A, Exp 06/2023, BAC0533A, Exp 10/2023, BAD0148A, Exp 03/2024, BAD0320A, Exp 07/2024

Recall started

July 5, 2023

Recall number

D-0924-2023

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0924-2023. The agency record governs; check it and the company before acting.