Last Updated on October 10, 2024 by The Health Master
IBSA Pharma Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level.
This voluntary recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.
Risk Statement:
Patients being treated for hypothyroidism (underactive thyroid), who receive subpotent TIROSINT®-SOL, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.
Over- or under-treatment with TIROSINT® SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism.
Any patients including those who might be pregnant, newborn infants, or elderly patients, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
To date, IBSA Pharma Inc. has not received any reports of adverse events that have been determined to be related to this voluntary recall.
This drug is indicated for:
- Hypothyroidism – As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
- Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression – As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well differentiated thyroid cancer.
The product description, NDC numbers, lot numbers, and expiration dates of affected drug lots are shown in the table below:
| Product Description | NDC | Lot Number | Expiration Date |
|---|---|---|---|
| TIROSINT-SOL 13 mcg/mL 30 units carton-box | 71858-0105-5 | 220409 | 10/2023 |
| TIROSINT-SOL 13 mcg/mL 30 units carton-box | 71858-0105-5 | 220956 | 03/2024 |
| TIROSINT-SOL 25 mcg/mL 30 units carton-box | 71858-0110-5 | 220856 | 02/2024 |
| TIROSINT-SOL 37.5 mcg/mL 30 units carton-box | 71858-0112-5 | 220552 | 11/2023 |
| TIROSINT-SOL 37.5 mcg/mL 30 units carton-box | 71858-0112-5 | 221055 | 04/2024 |
| TIROSINT-SOL 44 mcg/mL 30 units carton-box | 71858-0113-5 | 220553 | 11/2023 |
| TIROSINT-SOL 44 mcg/mL 30 units carton-box | 71858-0113-5 | 221056 | 04/2024 |
| TIROSINT-SOL 50 mcg/mL 30 units carton-box | 71858-0115-5 | 220407 | 10/2023 |
| TIROSINT-SOL 50 mcg/mL 30 units carton-box | 71858-0115-5 | 220960 | 03/2024 |
| TIROSINT-SOL 62.5 mcg/mL 30 units carton-box | 71858-0117-5 | 220556 | 11/2023 |
| TIROSINT-SOL 62.5 mcg/mL 30 units carton-box | 71858-0117-5 | 221058 | 04/2024 |
| TIROSINT-SOL 75 mcg/mL 30 units carton-box | 71858-0120-5 | 220853 | 02/2024 |
| TIROSINT-SOL 88 mcg/mL 30 units carton-box | 71858-0125-5 | 220411 | 10/2023 |
| TIROSINT-SOL 88 mcg/mL 30 units carton-box | 71858-0125-5 | 220854 | 02/2024 |
| TIROSINT-SOL 100 mcg/mL 30 units carton-box | 71858-0130-5 | 220413 | 10/2023 |
| TIROSINT-SOL 100 mcg/mL 30 units carton-box | 71858-0130-5 | 220964 | 03/2024 |
| TIROSINT-SOL 112 mcg/mL 30 units carton-box | 71858-0135-5 | 220414 | 10/2023 |
| TIROSINT-SOL 112 mcg/mL 30 units carton-box | 71858-0135-5 | 220852 | 02/2024 |
| TIROSINT-SOL 112 mcg/mL 30 units carton-box | 71858-0135-5 | 220970 | 03/2024 |
| TIROSINT-SOL 125 mcg/mL 30 units carton-box | 71858-0140-5 | 220855 | 02/2024 |
| TIROSINT-SOL 137 mcg/mL 30 units carton-box | 71858-0145-5 | 220415 | 10/2023 |
| TIROSINT-SOL 137 mcg/mL 30 units carton-box | 71858-0145-5 | 221052 | 04/2024 |
| TIROSINT-SOL 150 mcg/mL 30 units carton-box | 71858-0150-5 | 220959 | 03/2024 |
| TIROSINT-SOL 175 mcg/mL 30 units carton-box | 71858-0155-5 | 220416 | 10/2023 |
| TIROSINT-SOL 175 mcg/mL 30 units carton-box | 71858-0155-5 | 221053 | 04/2024 |
| TIROSINT-SOL 200 mcg/mL 30 units carton-box | 71858-0160-5 | 220418 | 10/2023 |
| TIROSINT-SOL 200 mcg/mL 30 units carton-box | 71858-0160-5 | 220560 | 11/2023 |
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
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