LIOTHYRONINE SODIUM Recall D-0150-2024
Description: Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
LIOTHYRONINE SODIUM Recall D-0150-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0150-2024 |
| Event ID | 93542 |
| Brand | LIOTHYRONINE SODIUM |
| Generic Name | LIOTHYRONINE SODIUM |
| Manufacturer | LIOTHYRONINE SODIUM |
| Original Package? | 1 |
| Active Substance | LIOTHYRONINE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 96,192 bottles |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20231220 |
| Product NDC | 62756-589 62756-590 62756-591 |
| Recall Initiation Date | 20231204 |
| Report Date | 20231220 |
| Classification Date | 20231214 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | GCA9VV7D2N |
| Drug Application Number | ANDA091382 |
| Structured Product Labeling (SPL ID) | af12cd5c-3963-4ef2-b819-a42343f0cb69 |
| Structured Product Labeling (SPL Set ID) | 892e63ef-3a60-45fa-b12b-d6795acc0956 |
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