FDA Drug recall D-1499-2022
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07…
- FDA Drug
- Class II
- terminated
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07… by Cipla, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1499-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-22 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla |
| Distribution | US |
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.
Reason
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.
Identifiers
| ndc | 69097-341-35 |
|---|---|
| code_info | Lot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/…Lot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023 |
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-1499-2022%22
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