Difluprednate Ophthalmic Emulsion 0 recalled over sterility concerns

Recall date

August 2, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CIPLA recalls Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., In…

Recall number

D-1328-2022

FDA classification

Class II

Brand / firm

CIPLA

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Complaints received of defective container closure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.