LEVOTHYROXINE SODIUM Recall D-0076-2025
Description: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
LEVOTHYROXINE SODIUM Recall D-0076-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0076-2025 |
| Event ID | 95747 |
| Brand | LEVOTHYROXINE SODIUM |
| Generic Name | LEVOTHYROXINE SODIUM |
| Manufacturer | LEVOTHYROXINE SODIUM |
| Original Package? | 1 |
| Active Substance | LEVOTHYROXINE SODIUM |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Recall Reason | Subpotent drug |
| Drug Classification | Class II |
| Drug Code Info | 20241211 |
| Product NDC | 16729-447 16729-458 16729-448 |
| Drug UPC | 0316729447157 0316729449151 0316729452151 |
| Recall Initiation Date | 20241108 |
| Report Date | 20241211 |
| Classification Date | 20241129 |
| Address | 8041 Arco Corporate Dr Ste 200 Raleigh, NC 27617-2010 United States |
| Recalling Firm | ACCORD HEALTHCARE, INC. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9J765S329G |
| Drug Application Number | ANDA212399 |
| Structured Product Labeling (SPL ID) | 26408e81-f136-15ca-e063-6394a90a6fb6 |
| Structured Product Labeling (SPL Set ID) | a6233381-3043-4e9a-aaa6-a6b105e5142b |
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