LEVOTHYROXINE SODIUM Recall D-0127-2025
Description: Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
LEVOTHYROXINE SODIUM Recall D-0127-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0127-2025 |
| Event ID | 95768 |
| Brand | LEVOTHYROXINE SODIUM |
| Generic Name | LEVOTHYROXINE SODIUM |
| Manufacturer | LEVOTHYROXINE SODIUM |
| Original Package? | 1 |
| Active Substance | LEVOTHYROXINE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States and Puerto Rico |
| Quantity | 65,169 |
| Recall Reason | Superpotent Drug and Subpotent Drug: potency failures obtained |
| Drug Classification | Class II |
| Drug Code Info | 20241218 |
| Product NDC | 0378-1800 0378-1803 0378-1805 |
| Recall Initiation Date | 20241118 |
| Report Date | 20241218 |
| Classification Date | 20241212 |
| Address | 1000 Mylan Blvd Canonsburg, PA 15317-5853 United States |
| Recalling Firm | Viatris Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9J765S329G |
| Drug Application Number | ANDA076187 |
| Structured Product Labeling (SPL ID) | ca193039-55b1-4a7e-aa67-c4bff4f9f5b0 |
| Structured Product Labeling (SPL Set ID) | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc |
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