Drug 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.
D-1328-2022
Product summary
- Firm
- CIPLA
- Event
- Event 90702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,992 bottles
- Official record key
drug-enforcement:D-1328-2022
Official wording
Reason: Lack of Assurance of Sterility: Complaints received of defective container closure.
Code information: Lot # DEG3LC2, Exp 05/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility