Subpotent Oral Solution Prompts Recall of Hypothyroidism Treatment

IBSA Pharma Inc. announced the voluntary recall of 27 lots of Tirosint^®-SOL (levothyroxine sodium) oral solution to the consumer level due to subpotency.

Tirosint-SOL is indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well differentiated thyroid cancer.

Testing of the oral solution revealed a slight decrease below 95% of the labeled amount in levothyroxine sodium (T4) for some lots. This recall does not apply to Tirosint (levothyroxine sodium) capsules.

Tirosint-SOL oral solution is supplied as 1mL unit dose ampules in 30-unit cartons. The 27 recalled lots were distributed to wholesalers, pharmacies, and health care providers. A complete list of recalled products can be found here.

To date, the Company has not received any reports of adverse events related to this recall. Adverse reactions or quality problems should be reported to the FDA’s MedWatch program.

Reference

IBSA Pharma Inc. issues voluntary nationwide recall of select lots of Tirosint^®-SOL (levothyroxine sodium) oral solution due to subpotency. News release. IBSA Pharma Inc. February 1, 2023. Accessed February 3, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ibsa-pharma-inc-issues-voluntary-nationwide-recall-select-lots-tirosintr-sol-levothyroxine-sodium.