NETSPOT

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

A quality defect of the NETSPOT product was identified – stability test results showed the content of the active substance DOTATATE close to the lower limit of the specification, meaning that established quality requirements are not met. Potential effects: lack of diagnostic efficacy, risk of delayed disease diagnosis.

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Risk Level

Critical

Manufacturer

Advanced Accelerator Applications USA

Batch Number

PG1921019, PG1921020

Notice Date

12.04.2022

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 batches PG1921019 and PG1921020. Check the batch number of the product in possession and, if it matches, return it to the dispensing entity and consult a physician regarding further managem...

Actions Taken

The Chief Pharmaceutical Inspector withdrew NETSPOT batches PG1921019 and PG1921020 from the market throughout the country and granted the decision immediate enforceability, obliging the marketing aut...

Need Help?

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

NETSPOT

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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