3% ROZTWÓR KWASU BOROWEGO

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 was found: boric acid content is 0.3% instead of 2.8%-3.2% and the form is non-compliant, which may lead to compounded medicines with incorrect strength and efficacy. Potential effects: lack of therapeutic efficacy, possible disease complications.

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Risk Level

Critical

Manufacturer

Zakład Farmaceutyczny Amara Sp. z o.o.

Notice Date

19.06.2019

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Do not use the 3% boric acid solution from the withdrawn batch for any purpose or for compounding prescriptions; pharmacies should immediately stop using the raw material and return it according to th...

Actions Taken

The Chief Pharmaceutical Inspector issued a decision to withdraw from the market throughout the country the batch of the pharmaceutical raw material 3% boric acid solution and granted the decision imm...

Need Help?

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

3% ROZTWÓR KWASU BOROWEGO

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

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