GIF withdraws series of popular thyroid drug from market

The Chief Pharmaceutical Inspector has issued decision No. 40/WC/ZW/2025, ordering the withdrawal of the series of the drug Euthyrox N 25 mcg, tablets, 100 units, with the number G02PXT, with an expiration date of 29.02.2028, from the market nationwide. The responsible entity is Merck sp. z o.o., based in Warsaw. The decision also includes a marketing ban on the indicated batch and has been made immediately enforceable.

Out of specification result

According to GIF, the notification of non-compliance came from the responsible party itself. Long-term stability testing yielded an out-of-specification (OOS) result in the parameter for the active substance content. This means that in part of the samples, the level of the hormone exceeded the upper quality limit set for this product.

Although additional analyses yielded an average value that was within the limit of the standard, there were exceedances among individual results. Merck pointed to "a tendency toward slightly higher content determination results combined with analytical variability" as the most likely cause.

What is Euthyrox N 25 used for?

Euthyrox N 25 mcg is a prescription drug containing levothyroxine, a synthetic thyroid hormone. It is used in, among other things:

• Treatment of hypothyroidism (substitution when the thyroid gland does not produce enough hormones),
  
• The treatment of goiter in adults,
  
• Suppressive therapy after thyroid cancer treatment,
  
• Supporting the effects of antithyroid drugs.
  

The preparation is one of the most widely used hormonal drugs in Poland.

Source: GIF