Recall D-0679-2022
Description: Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
Recall D-0679-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0679-2022 |
| Event ID | 89798 |
| Brand | DICLOVIX M |
| Generic Name | DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH |
| Manufacturer | DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH |
| Original Package? | 1 |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 16,643 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 | 72275-719 |
| 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 |
| Drug Application Number | ANDA202769 |
| Structured Product Labeling (SPL ID) | 9d001257-2092-2a0c-e053-2a95a90ad767 |
| Structured Product Labeling (SPL Set ID) | 9d0012ed-a50a-a936-e053-2995a90a6100 |
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