VITAMINUM A + E SYNTEZA

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.

The absence of a unique identifier and tamper‑evident device, together with placing batches on the market without proper certification and release by the Qualified Person, may result in incorrect identification, risk of falsification, or lack of confirmed quality and safety of therapy. Potential effects: lack of efficacy, treatment complications.

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Risk Level

High

Manufacturer

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

Batch Number

Spasmolina 60 mg: 091016 (data ważności 10.2019) i 010119 (data ważności 01.2022); Andepin 20 mg: 010119 (data ważności 01.2021); Kalium effervescens bezcukrowy 782 mg jonów potasu/3 g: 040219 i 050219 (data ważności 07.2021)

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 products from the listed batches. Check the batch number and expiry date on the packaging. If you possess such packs, return them to the pharmacy or wholesaler; if you have any doubts about...

Actions Taken

The Chief Pharmaceutical Inspector withdrew from the market Spasmolina 60 mg hard capsules, batch 091016 (expiry 10.2019) and the batches: Spasmolina 60 mg 010119, Andepin 20 mg 010119, Kalium efferve...

Need Help?

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

VITAMINUM A + E SYNTEZA

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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