CIPLA recalls Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., Ind
Recalled August 17, 2022 · FDA recall D-1328-2022 · CIPLA
Hazard
Lack of Assurance of Sterility: Complaints received of defective container closure. · FDA Class II
Units
7,992 bottles
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility: Complaints received of defective container closure.
Product
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.
Manufacturer(s)
CIPLA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →