Drug product
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35.
D-1283-2022
Product summary
- Firm
- CIPLA
- Event
- Event 90608
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,136 bottles
- Official record key
drug-enforcement:D-1283-2022
Official wording
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.
Code information: Batch# DEG4LC2, exp. date 05/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility