DICLOFENAC SODIUM Recall D-0680-2022
Description: Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
DICLOFENAC SODIUM Recall D-0680-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0680-2022 |
| Event ID | 89798 |
| Brand | DICLOFENAC SODIUM 1.5% |
| Generic Name | DICLOFENAC SODIUM TOPICAL SOLUTION |
| Manufacturer | DICLOFENAC SODIUM TOPICAL SOLUTION |
| Original Package? | 1 |
| Active Substance | DICLOFENAC SODIUM |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 36,018 bottles |
| Recall Reason | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Product NDC | 70512-025 |
| Drug UPC | 0370512025052 |
| Recall Initiation Date | 20220315 |
| Report Date | 20220330 |
| Classification Date | 20220321 |
| Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
| Recalling Firm | Teligent Pharma, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | QTG126297Q |
| Drug Application Number | ANDA202769 |
| Structured Product Labeling (SPL ID) | b8bd41e9-b7a5-5daa-e053-2a95a90ad691 |
| Structured Product Labeling (SPL Set ID) | 5e1f20e0-4743-fc3c-e053-2991aa0aa7ad |
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