Clopidogrel Genoptim

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A result outside the quality specification was found for the parameters: clopidogrel-related substances — impurity A and enantiomeric purity — impurity C, which may affect the safety and efficacy of the medicine. Potential effects: lack of treatment efficacy or adverse reactions.

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Risk Level

Medium

Manufacturer

Synoptis Pharma Sp. z o.o.

Batch Number

170702488

Notice Date

25.10.2019

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 medicine from batch 170702488, check the batch number on the package and, if it matches, return the product to the pharmacy; in case of doubts or adverse reactions, contact a doctor.

Actions Taken

Withdrawal from the market throughout the country of batch 170702488 of Clopidogrel Genoptim and granting the decision immediate enforceability.

Need Help?

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

Clopidogrel Genoptim

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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