FOLACID

GIF decision: Marketing prohibition

What does this decision mean?

• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Incorrect expiry date was printed, the prescription products lacked a unique identifier and tamper-evident safety feature on the packaging, and batches were not certified or released by a Qualified Person. Potential effects: lack of efficacy, use after expiry date, risk of falsification, therapy complications.

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Risk Level

High

Manufacturer

Przedsiębiorstwo Farmaceutyczno-Chemiczne SYNTEZA Sp. z o.o.

Batch Number

Spasmolina: 091016, 010119; Andepin: 010119; Kalium effervescens bezcukrowy: 040219, 050219

Notice Date

26.04.2019

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 the specified batches, check the batch number and expiry date on the packaging, if you have these batches return them to the pharmacy or wholesaler, and consult a doctor or pharmacist if in...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of medicinal products from the market and banned the placing on the market of the manufacturer’s products that do not meet the require...

Need Help?

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

FOLACID

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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