DIFLUPREDNATE Recall D-1498-2022
Description: Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
DIFLUPREDNATE Recall D-1498-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1498-2022 |
| Event ID | 90796 |
| Brand | DIFLUPREDNATE |
| Generic Name | DIFLUPREDNATE |
| Manufacturer | DIFLUPREDNATE |
| Original Package? | 1 |
| Active Substance | DIFLUPREDNATE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 3,468 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 | 20220914 |
| Product NDC | 76282-708 |
| Recall Initiation Date | 20220822 |
| Report Date | 20220914 |
| Classification Date | 20220907 |
| 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) | 8cddb271-2bf9-4493-b5cf-547f56c46caf |
| Structured Product Labeling (SPL Set ID) | f7744cc9-bc5b-4642-8b36-07136704910a |
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