FDA Drug recall D-1328-2022
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured fo…
- FDA Drug
- Class II
- terminated
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured fo… by Cipla, citing lack of Assurance of Sterility: Complaints received of defective container closure.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1328-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-02 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla |
| Distribution | US |
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.
Reason
Lack of Assurance of Sterility: Complaints received of defective container closure.
Identifiers
| ndc | 69097-341-35 |
|---|---|
| code_info | Lot # DEG3LC2, Exp 05/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1328-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.