LEVOTHYROXINE SODIUM Recall D-0353-2023
Description: Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
LEVOTHYROXINE SODIUM Recall D-0353-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0353-2023 |
| Event ID | 91654 |
| Brand | LEVOTHYROXINE SODIUM |
| Generic Name | LEVOTHYROXINE SODIUM |
| Manufacturer | LEVOTHYROXINE SODIUM |
| Original Package? | 1 |
| Active Substance | LEVOTHYROXINE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide and Puerto Rico. |
| Quantity | 21,276 bottles |
| Recall Reason | Sub-Potent Drug: Out of specification for assay at the 24 month interval. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 47781-640 47781-643 47781-646 |
| Drug UPC | 0347781659905 0347781651909 0347781657901 |
| Recall Initiation Date | 20230206 |
| Report Date | 20230308 |
| Classification Date | 20230224 |
| Address | 44 Whippany Rd Ste 107 Morristown, NJ 07960-4558 United States |
| Recalling Firm | Alvogen, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9J765S329G |
| Drug Application Number | NDA021116 |
| Structured Product Labeling (SPL ID) | 4f2514ab-b435-4b20-adaf-93b63c80feda |
| Structured Product Labeling (SPL Set ID) | 4ddcaec1-a58f-340b-9bc1-bbe048b8c885 |
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