DIFLUPREDNATE Recall D-1283-2022
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.
DIFLUPREDNATE Recall D-1283-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1283-2022 |
| Event ID | 90608 |
| Brand | DIFLUPREDNATE |
| Generic Name | DIFLUPREDNATE |
| Manufacturer | DIFLUPREDNATE |
| Original Package? | 1 |
| Active Substance | DIFLUPREDNATE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 8,136 bottles |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20220727 |
| Product NDC | 69097-341 |
| Recall Initiation Date | 20220714 |
| Report Date | 20220727 |
| Classification Date | 20220720 |
| Address | 10 Independence Blvd Warren, NJ 07059-2730 United States |
| Recalling Firm | CIPLA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | S8A06QG2QE |
| Drug Application Number | ANDA211776 |
| Structured Product Labeling (SPL ID) | 825a55a7-ffdf-4fde-bbb2-486cbd16e602 |
| Structured Product Labeling (SPL Set ID) | 8a7254de-a7a2-476d-9295-c41926267ec9 |
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