D-1283-2022 Class II Terminated
FDA drug recall D-1283-2022 was initiated by CIPLA on Jul 14, 2022 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Nov 27, 2023). Affected quantity: 8,136 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 27, 2022
- Initiation Date
- Jul 14, 2022
- Termination Date
- Nov 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,136 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Batch# DEG4LC2, exp. date 05/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1283-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026