CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cip
Recalled September 14, 2022 · FDA recall D-1499-2022 · 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
117,844 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 by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Manufacturer(s)
CIPLA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →