Hydroxyzinum Hasco

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

An increase of an unknown impurity was detected in the 'other single' parameter for hydroxyzine hydrochloride after a production pH-meter failure, resulting in non-compliance with quality specifications. Potential effects: unknown toxic effects, adverse reactions, reduced medicine quality.

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Risk Level

Medium

Manufacturer

Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. z siedzibą we Wrocławiu

Batch Number

010624

Notice Date

05.11.2024

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 products from batches 010624 and 020624; check the batch number; return to the pharmacy or contact the marketing authorisation holder. If adverse symptoms occur, consult a physician.

Actions Taken

Withdrawn from the market nationwide for batches 010624 and 020624; prohibition on placing the specified batches on the market; decision made with immediate enforceability.

Need Help?

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

Hydroxyzinum Hasco

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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