TIROSINT-SOL recall announced due to subpotency

TIROSINT-SOL recall

• Who: IBSA Pharma Inc. issued a nationwide recall of certain lots of TIROSINT-SOL. 
• Why: The recalled product may not be as potent as advertised.
• Where: The TIROSINT-SOL recall is active in the United States.

IBSA Pharma Inc. issued a nationwide recall of certain lots of TIROSINT-SOL as the product may not be as potent as advertised.

The U.S. Food & Drug Administration website published  the recall on Feb. 1. It includes 27 lots of TIROSINT-SOL (levothyroxine sodium) Oral Solution sold at the consumer level in a range of different sizes and lot numbers. To identify if you have one of the recalled products, click here. 

IBSA initiated the TIROSINT-SOL recall because certain lots may be subpotent, the company says. It says analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium for some lots. 

“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,” the recall states.

The recall does not apply to TIROSINT capsules.

Consumers affected by TIROSINT-SOL recall should contact their healthcare provider, notice states

IBSA Pharma says it is notifying its wholesalers, retailers and healthcare providers to discontinue distribution of the recalled product and arranging for their return.

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, the recall states. 

“Patients who are currently taking TIROSINT-SOL should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription,” the TIROSINT-SOL recall says.

To date, the company has not received any reports of adverse events related to the recall, it says. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.

In other medicine recalls, earlier this year, Spectrum Laboratory Products Inc. recalled three lots of Epinephrine (L-Adrenaline) USP in the United States and Canada as customers complained that the product was discolored. 

Are you affected by this TIROSINT-SOL recall? Let us know in the comments! 

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