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WARNING: RECALLED PRODUCT
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3% ROZTWÓR KWASU BOROWEGO

A quality defect was found: too low boric acid content (should be 2.8%–3.2%, actual 0.3%) and non‑compliant form, which may lead to preparation of compounded medicines with incorrect strength and effectiveness. Potential effects: lack of drug efficacy, risk of therapy complications.

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3% ROZTWÓR KWASU BOROWEGO
Risk Level
High
Manufacturer
Zakład Farmaceutyczny Amara Sp. z o.o.
Recall Date
19.06.2019
View official statement

Important Information

What You Should Know

Recommendations

Do not use this raw material for compounding medicines. Pharmacies should check their stocks of 3% boric acid solution from Zakład Farmaceutyczny “Amara” and return them according to the withdrawal pr...

Actions Taken

The Chief Pharmaceutical Inspector decided to withdraw from the market throughout the country the specified 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.

FAQ

Frequently Asked Questions

Is this product safe to consume?
No. This product has been recalled due to: A quality defect was found: too low boric acid content (should be 2.8%–3.2%, actual 0.3%) and non‑compliant form, which may lead to preparation of compounded medicines with incorrect strength and effectiveness. Potential effects: lack of drug efficacy, risk of therapy complications.
What should I do if I already bought this?
Stop using the product immediately. Return it to the store for a full refund. If you consumed it and feel unwell, contact your doctor.
Which batches are affected?
Check the official report for specific batch details.

Related

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