Recall Enforment Report D-1499-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by CIPLA, originally initiated on 08-22-2022 for the 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. The product was recalled due to 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.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1499-202208-22-202209-14-2022Class II117,844 bottlesDifluprednate 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.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.Ongoing
D-1498-202208-22-202209-14-2022Class II3,468 bottlesDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.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.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
69097-341Difluprednate DifluprednateEmulsionOphthalmicCipla Usa Inc.Human Prescription Drug
76282-708Difluprednate DifluprednateEmulsionOphthalmicExelan Pharmaceuticals, Inc.Human Prescription Drug