LEVOTHYROXINE SODIUM Recall D-0336-2023
Description: TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0112-5
LEVOTHYROXINE SODIUM Recall D-0336-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0336-2023 |
| Event ID | 91556 |
| Brand | TIROSINT |
| Generic Name | LEVOTHYROXINE SODIUM |
| Manufacturer | LEVOTHYROXINE SODIUM |
| Original Package? | 1 |
| Active Substance | LEVOTHYROXINE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA. |
| Recall Reason | Subpotent Drug |
| Drug Classification | Class I |
| Drug Code Info | 20230301 |
| Product NDC | 71858-0105 71858-0110 71858-0112 |
| Recall Initiation Date | 20230130 |
| Report Date | 20230301 |
| Classification Date | 20230221 |
| Address | 8 Campus Dr Ste 201 Parsippany, NJ 07054-4409 United States |
| Recalling Firm | IBSA PHARMA INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9J765S329G |
| Drug Application Number | NDA206977 |
| Structured Product Labeling (SPL ID) | f1d5f04c-48ff-6a9f-e053-2a95a90a5f81 |
| Structured Product Labeling (SPL Set ID) | 5d378add-f13d-40f2-99dc-0f2340ab44b7 |
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