Viglita

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.

The product does not meet quality requirements due to an out-of-specification result for friability of uncoated tablets; the sample contained crushed, cracked or broken tablets. Potential effects: possible uneven dosing of the drug and reduced therapeutic efficacy.

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Risk Level

Medium

Manufacturer

Zentiva k.s. z siedzibą w Pradze, Republika Czeska

Batch Number

wszystkie serie (badana seria: CLB05146)

Notice Date

16.05.2024

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 Viglita (Vildagliptin) 50 mg due to suspension of all batches; patients should contact their doctor or pharmacist to determine further treatment and a possible change of medication.

Actions Taken

The Chief Pharmaceutical Inspector suspended the marketing of Viglita (Vildagliptin) 50 mg tablets throughout the country for all batches and granted the decision immediate enforceability; previously,...

Need Help?

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

Viglita

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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