IBSA Pharma Inc. has announced a voluntary recall of 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution due to concern for subpotency. Company testing revealed a slight decrease below 95% of the labeled amount of levothyroxine sodium for some lots. This recall does not apply to TIROSINT® (levothyroxine sodium) capsules. To date, IBSA has not received any reports of adverse events that have been determined to be related to this recall.
The 27 recalled lots were distributed to wholesalers, pharmacies, and health care providers. A complete list of recalled products can be found here. IBSA Pharma Inc. is proactively notifying its wholesalers, retailers and health care providers to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Consumers and healthcare providers with questions regarding this recall can contact IBSA Pharma Inc. by phone at 1-800-587-3513 Monday through Friday between 9:00 am and 7:00 pm (EST), or by e-mail at email@example.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.
Up to date as of February 8, 2023