CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton

Recalled September 14, 2022 · FDA recall D-1498-2022 · CIPLA

Hazard

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. · FDA Class II

Units

3,468 bottles

Sold at

Nationwide in the USA

Description

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.

Product

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.

Manufacturer(s)

CIPLA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →