LECALPIN

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

It was found that in the outer cartons intended for the medicinal product Lecalpin 20 mg there were primary packages (blisters) of the medicinal product Lecalpin 10 mg, batch No. 268018. Potential effects: lack of treatment efficacy or improper dosing.

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Risk Level

High

Manufacturer

Aurobindo Pharma B.V. Holandia

Batch Number

268018

Notice Date

21.05.2019

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 Lecalpin 10 mg and Lecalpin 20 mg products with batch number 268018, check the batch number on the packaging and, if you have these products, return them to the pharmacy or contact a pharma...

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw Lecalpin 10 mg and Lecalpin 20 mg products, batch No. 268018, from the market with immediate enforceability; the company was obliged to...

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

Recommendations

Actions Taken

Need Help?

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