DICLOFENAC SODIUM Recall D-0714-2022
Description: Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
DICLOFENAC SODIUM Recall D-0714-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0714-2022 |
| Event ID | 89807 |
| Brand | DICLOFENAC SODIUM |
| Generic Name | DICLOFENAC SODIUM |
| Manufacturer | DICLOFENAC SODIUM |
| Active Substance | DICLOFENAC SODIUM |
| Drug Route | TOPICAL |
| Distribution | Nationwide within the United States |
| Quantity | 312 bottles |
| Recall Reason | Defective Container: Leaking containers. |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Product NDC | 61919-675 61919-874 |
| Recall Initiation Date | 20211207 |
| Report Date | 20220330 |
| Classification Date | 20220322 |
| Address | 94 Worldwide Dr Dawsonville, GA 30534-6828 United States |
| Recalling Firm | Direct Rx |
| Initial Notification | Letter |
| Unique Ingredient Identifier | QTG126297Q |
| Drug Application Number | ANDA202769 |
| Structured Product Labeling (SPL ID) | 94e0cb71-8733-d8a5-e053-2995a90a6792 |
| Structured Product Labeling (SPL Set ID) | 3d976518-60d2-478a-e054-00144ff88e88 |
| Similar To |