D-1328-2022 Class II Terminated
FDA drug recall D-1328-2022 was initiated by CIPLA on August 2, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Complaints received of defective container closure. The recall status is terminated (terminated November 27, 2023). Affected quantity: 7,992 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 17, 2022
- Initiation Date
- August 2, 2022
- Termination Date
- November 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,992 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # DEG3LC2, Exp 05/2023