Risperidone Teva

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Testing by the National Medicines Institute showed out-of-specification results for the release parameter and particle size analysis; the critical role of active substance release for the product’s efficacy and safety was emphasized. Potential effects: lack of treatment efficacy, possible adverse reactions or therapy-related complications.

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Risk Level

Critical

Manufacturer

Teva B.V. z siedzibą w Haarlem, Holandia

Batch Number

wszystkie serie (badana seria: 4201373)

Notice Date

31.12.2024

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use this medicinal product from the suspended batches. Patients should contact their physician to determine further treatment and possible replacement of the product.

Actions Taken

The Chief Pharmaceutical Inspector suspended distribution of the medicinal product nationwide for all batches and granted the decision immediate enforceability; the product had previously been sent fo...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Risperidone Teva

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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