Clopidogrel Genoptim

GIF decision: Re-authorization for marketing

What does this decision mean?

• Ponowne dopuszczenie do obrotu — The product has been re-authorized for marketing after earlier restrictions.

The previously identified quality defect was the placement of an incorrect active substance name on the unit packaging of the medicinal product Clopidogrel Genoptim. Potential effects: incorrect use of the medicine, lack of treatment efficacy, possible treatment complications.

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Risk Level

High

Manufacturer

Synoptis Pharma Sp. z o.o.

Batch Number

1808325, 1808326, 1808327

Notice Date

03.04.2020

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

Patients may use the product from the listed batches according to their doctor’s recommendations; if there are any doubts about the packaging, consult a pharmacist or doctor.

Actions Taken

The decision to withdraw batches 1808325, 1808326, 1808327 of Clopidogrel Genoptim from the market was fully revoked after submission of documentation confirming correct repackaging and storage.

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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