Class I Recall for Thyroid Medication

IBSA Pharma Inc is voluntarily recalling more than 2 dozen lots of Tirosint-SOL (levothyroxine sodium) oral solution because the medication may be subpotent. The recall appeared in the March 1, 2023, US Food and Drug Administration (FDA) Enforcement Report.

“The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots,” IBSA Pharma stated in a January 31, 2023, announcement.

The FDA has designated the recall Class I, a classification that warns use of the affected medication could cause serious adverse health consequences or death.

The recalls affects the following products, which were manufactured by IBSA Institut Biochimique SA, Pazzallo, Switzerland, and distributed by IBSA Pharma, Parsippany, New Jersey, throughout the United States:

• Tirosint-SOL oral solution, 13 mcg/mL, 30-unit carton-box (NDC 71858-0105-5), from lots 220409 (Exp. 10/23) and 220956 (Exp. 3/24);
• Tirosint-SOL oral solution, 25 mcg/mL, 30-unit carton-box (NDC 71858-0110-5), from lot 220856 (Exp. 2/24);
• Tirosint-SOL oral solution, 37.5 mcg/mL, 30-unit carton-box (NDC 71858-0112-5), from lots 220552 (Exp. 11/23) and 221055 (Exp. 4/24);
• Tirosint-SOL oral solution, 44 mcg/mL, 30-unit carton-box (NDC 71858-0113-5), from lots 220553 (Exp. 11/23) and 221056 (Exp. 4/24);
• Tirosint-SOL oral solution, 50 mcg/mL, 30-unit carton-box (NDC 71858-0115-5), from lots 220407 (Exp. 10/23) and 220960 (Exp. 3/24);
• Tirosint-SOL oral solution, 62.5 mcg/mL, 30-unit carton-box (NDC 71858-0117-5), from lots 220556 (Exp. 11/23) and 221058 (Exp. 4/24);
• Tirosint-SOL oral solution, 75 mcg/mL, 30-unit carton-box (NDC 71858-0120-5), from lot 220853 (Exp. 2/24);
• Tirosint-SOL oral solution, 88 mcg/mL, 30-unit carton-box (NDC 71858-0125-5), from lots 220411 (Exp. 10/23) and 220854 (Exp. 2/24);
• Tirosint-SOL oral solution, 100 mcg/mL, 30-unit carton-box (NDC 71858-0130-5), from lots 220413 (Exp. 10/23) and 220964 (Exp. 3/24);
• Tirosint-SOL oral solution, 112 mcg/mL, 30-unit carton-box (NDC 71858-0135-5), from lots 220414 (Exp. 10/23), 220852 (Exp. 2/24), and 220970 (Exp. 3/24);
• Tirosint-SOL oral solution, 125 mcg/mL, 30-unit carton-box (NDC 71858-0140-5), from lot 220855 (Exp. 2/24);
• Tirosint-SOL oral solution, 137 mcg/mL, 30-unit carton-box (NDC 71858-0145-5), from lots 220415 (Exp. 10/23) and 221052 (Exp. 4/24);
• Tirosint-SOL oral solution, 150 mcg/mL, 30-unit carton-box (NDC 71858-0150-5), from lot 220959 (Exp. 3/24);
• Tirosint-SOL oral solution, 175 mcg/mL, 30-unit carton-box (NDC 71858-0155-5), from lots 220416 (Exp. 10/23) and 221053 (Exp. 4/24); and
• Tirosint-SOL oral solution, 200 mcg/mL, 30-unit carton-box (NDC 71858-0160-5), from lots 220418 (Exp. 10/23) and 220560 (Exp. 11/23).

IBSA Pharma initiated the recall, which does not apply to Tirosint capsules, on January 30, 2023. The FDA issued its Class I designation February 21, 2023.

Tirosint-SOL is a prescription drug used as replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism. It is also used as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent, well-differentiated thyroid cancer.

“Patients being treated for hypothyroidism (underactive thyroid), who receive subpotent Tirosint-SOL, may experience signs and symptoms of hypothyroidism...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,” IBSA Pharma advised.