ROTARIX

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Irregularities in the manufacturing process were detected, leading to possible insufficient filling of the last 50 oral applicators of the Rotarix batch, meaning failure to meet quality requirements for the volume parameter. Potential effects: lack of vaccination efficacy.

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Risk Level

High

Manufacturer

GlaxoSmithKline Biologicals S.A. Belgia

Notice Date

22.03.2019

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 product from batch AROLC214AE; patients and caregivers should check the batch number, return the product to the pharmacy or doctor, and consult a physician about the need for re-vaccination...

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw the medicinal product Rotarix batch AROLC214AE from the market throughout the country and granted the decision immediate enforceability; the mark...

Need Help?

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

ROTARIX

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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