Difluprednate Ophthalmic Emulsion recalled over sterility concerns

Recall date

August 22, 2022

Source

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

Official notice title

CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Ci…

Recall number

D-1499-2022

FDA classification

Class II

Brand / firm

CIPLA

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

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%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.