LEVOTHYROXINE SODIUM Recall D-0133-2025
Description: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20
LEVOTHYROXINE SODIUM Recall D-0133-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0133-2025 |
| Event ID | 95817 |
| Brand | LEVOTHYROXINE SODIUM |
| Generic Name | LEVOTHYROXINE SODIUM |
| Manufacturer | LEVOTHYROXINE SODIUM |
| Active Substance | LEVOTHYROXINE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA. |
| Quantity | 1,664 cartons |
| Recall Reason | Subpotent and Superpotent Drug |
| Drug Classification | Class II |
| Drug Code Info | 20241218 |
| Product NDC | 51079-440 51079-444 51079-441 |
| Recall Initiation Date | 20241119 |
| Report Date | 20241218 |
| Classification Date | 20241212 |
| Address | 1718 Northrock Ct Rockford, IL 61103-1201 United States |
| Recalling Firm | Mylan Institutional, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9J765S329G |
| Drug Application Number | ANDA076187 |
| Structured Product Labeling (SPL ID) | 240f18dd-91b9-fd32-e063-6394a90a3fea |
| Structured Product Labeling (SPL Set ID) | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 |
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