KALIUM EFFERVRSCENS BEZCUKROWY

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 on the packaging and the packs lacked a unique identifier and tamper-evident safety feature, as well as batch certification by the Qualified Person. Potential effects: lack of treatment efficacy or use of the product after expiry, possible complications.

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Risk Level

High

Manufacturer

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

Batch Number

091016

Notice Date

26.04.2019

What You Should Know

Recommendations

Do not use product from batch 091016, check the batch number on the pack and, if you have this batch, return it to the pharmacy or wholesaler; in case of doubts, contact a doctor or pharmacist.

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw batch 091016 of Spasmolina 60 mg hard capsules from the market and to withdraw other batches of the manufacturer’s products that did not meet saf...

Need Help?

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

KALIUM EFFERVRSCENS BEZCUKROWY

What You Should Know

Recommendations

Actions Taken

Need Help?

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