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 terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1499-2022 | 08-22-2022 | 09-14-2022 | Class II | 117,844 bottles | 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. | 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. | Terminated |
| D-1498-2022 | 08-22-2022 | 09-14-2022 | Class II | 3,468 bottles | Difluprednate 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. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 69097-341 | Difluprednate | Difluprednate | Emulsion | Ophthalmic | Cipla Usa Inc. | Human Prescription Drug |
