Lecalpin

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 defect was reported due to the detection of Lecalpin 10 mg blisters, batch 268018, inside outer cartons intended for Lecalpin 20 mg. Potential effects: possible intake of an incorrect dose and reduced treatment efficacy.

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Risk Level

High

Manufacturer

InPharm Sp. z o.o.

Batch Number

268018

Notice Date

03.01.2020

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

Check the strength of the medicine and the batch number on the packaging; if there is any doubt about the correct dose, consult a pharmacist or doctor and do not use the product in a manner inconsiste...

Actions Taken

The Chief Pharmaceutical Inspector revoked the previous decision to withdraw batch 268018 of Lecalpin 10 mg from the entire national market after reviewing documentation confirming proper storage, tra...

Need Help?

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

Lecalpin

What to do if you have this product?

What You Should Know

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Actions Taken

Need Help?

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