IBSA TIROSINT®-SOL (levothyroxine sodium) - recalled due to subpotency, USA

United States

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. This recall does not apply to TIROSINT® (levothyroxine sodium) capsules. To date, IBSA Pharma Inc. has not received any reports of adverse events that have been determined to be related to this voluntary recall.

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.

TIROSINT®-SOL 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.

TIROSINT®-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. The dosage strength is identified on the box and the pouch, and is associated with a distinct color. Each ampule bears a colored label with the dosage strength and the product name (TIROSINT®-SOL). For full prescribing information, visit www.TirosintSOL.com.

The product description, NDC numbers, lot numbers, and expiration dates of affected TIROSINT® SOL lots are shown below:

- Product Description: TIROSINT-SOL 13 mcg/mL 30 units carton-box. NDC: 71858-0105-5. Lot Number: 220409. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 13 mcg/mL 30 units carton-box. NDC: 71858-0105-5. Lot Number: 220956. Expiration Date: 3/1/2024.
- Product Description: TIROSINT-SOL 25 mcg/mL 30 units carton-box. NDC: 71858-0110-5. Lot Number: 220856. Expiration Date: 2/1/2024.
- Product Description: TIROSINT-SOL 37.5 mcg/mL 30 units carton-box. NDC: 71858-0112-5. Lot Number: 220552. Expiration Date: 11/1/2023.
- Product Description: TIROSINT-SOL 37.5 mcg/mL 30 units carton-box. NDC: 71858-0112-5. Lot Number: 221055. Expiration Date: 4/1/2024.
- Product Description: TIROSINT-SOL 44 mcg/mL 30 units carton-box. NDC: 71858-0113-5. Lot Number: 220553. Expiration Date: 11/1/2023.
- Product Description: TIROSINT-SOL 44 mcg/mL 30 units carton-box. NDC: 71858-0113-5. Lot Number: 221056. Expiration Date: 4/1/2024.
- Product Description: TIROSINT-SOL 50 mcg/mL 30 units carton-box. NDC: 71858-0115-5. Lot Number: 220407. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 50 mcg/mL 30 units carton-box. NDC: 71858-0115-5. Lot Number: 220960. Expiration Date: 3/1/2024.
- Product Description: TIROSINT-SOL 62.5 mcg/mL 30 units carton-box. NDC: 71858-0117-5. Lot Number: 220556. Expiration Date: 11/1/2023.
- Product Description: TIROSINT-SOL 62.5 mcg/mL 30 units carton-box. NDC: 71858-0117-5. Lot Number: 221058. Expiration Date: 4/1/2024.
- Product Description: TIROSINT-SOL 75 mcg/mL 30 units carton-box. NDC: 71858-0120-5. Lot Number: 220853. Expiration Date: 2/1/2024.
- Product Description: TIROSINT-SOL 88 mcg/mL 30 units carton-box. NDC: 71858-0125-5. Lot Number: 220411. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 88 mcg/mL 30 units carton-box. NDC: 71858-0125-5. Lot Number: 220854. Expiration Date: 2/1/2024.
- Product Description: TIROSINT-SOL 100 mcg/mL 30 units carton-box. NDC: 71858-0130-5. Lot Number: 220413. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 100 mcg/mL 30 units carton-box. NDC: 71858-0130-5. Lot Number: 220964. Expiration Date: 3/1/2024.
- Product Description: TIROSINT-SOL 112 mcg/mL 30 units carton-box. NDC: 71858-0135-5. Lot Number: 220414. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 112 mcg/mL 30 units carton-box. NDC: 71858-0135-5. Lot Number: 220852. Expiration Date: 2/1/2024.
- Product Description: TIROSINT-SOL 112 mcg/mL 30 units carton-box. NDC: 71858-0135-5. Lot Number: 220970. Expiration Date: 3/1/2024.
- Product Description: TIROSINT-SOL 125 mcg/mL 30 units carton-box. NDC: 71858-0140-5. Lot Number: 220855. Expiration Date: 2/1/2024.
- Product Description: TIROSINT-SOL 137 mcg/mL 30 units carton-box. NDC: 71858-0145-5. Lot Number: 220415. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 137 mcg/mL 30 units carton-box. NDC: 71858-0145-5. Lot Number: 221052. Expiration Date: 4/1/2024.
- Product Description: TIROSINT-SOL 150 mcg/mL 30 units carton-box. NDC: 71858-0150-5. Lot Number: 220959. Expiration Date: 3/1/2024.
- Product Description: TIROSINT-SOL 175 mcg/mL 30 units carton-box. NDC: 71858-0155-5. Lot Number: 220416. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 175 mcg/mL 30 units carton-box. NDC: 71858-0155-5. Lot Number: 221053. Expiration Date: 4/1/2024.
- Product Description: TIROSINT-SOL 200 mcg/mL 30 units carton-box. NDC: 71858-0160-5. Lot Number: 220418. Expiration Date: 10/1/2023.
- Product Description: TIROSINT-SOL 200 mcg/mL 30 units carton-box. NDC: 71858-0160-5. Lot Number: 220560. Expiration Date: 11/1/2023.

Patients who are currently taking TIROSINT®-SOL should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: IBSA Pharma Inc.
Brand name: IBSA
Product recalled: TIROSINT®-SOL (levothyroxine sodium)
Reason of the recall: Subpotency
FDA Recall date: February 01, 2023

Source: www.fda.gov