Difluprednate Ophthalmic Emulsion 0 — Class II drug recall D-1328-2022
Terminated recall by CIPLA, reported 2022-08-17, distributed nationwide. Lack of Assurance of Sterility: Complaints received of defective container closure.
| Recall number | D-1328-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIPLA, Warren, NJ, United States |
| Recall initiated | 2022-08-02 |
| Classified | 2022-08-05 |
| Reported by FDA | 2022-08-17 |
| Terminated | 2023-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 7,992 bottles |
| Reason classes | sterility, packaging |
| NDC | 69097-0341, 69097-0341-35 |
| Lot numbers | DEG3LC2 |
| Expiration dates | 2023-05 |
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 for recall
Lack of Assurance of Sterility: Complaints received of defective container closure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1328-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.