Acurenal

GIF decision: Marketing suspension

What does this decision mean?

  • Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

Stability testing and reference sample results showed that the batches covered by the decision do not meet the requirement for the parameter "Purity: content of impurity A", which constitutes a real and direct risk to patients' health or life. Potential effects: poisoning, lack of treatment efficacy, increased adverse effects.

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Acurenal
Risk Level
Critical
Manufacturer
Bausch Health Ireland Limited z siedzibą w Irlandii
Batch Number
80212781
Notice Date
09.08.2024
View official statement
Source: GIF view the official alert

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. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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. 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. 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 product from batches 80219782 and 80212781; check the batch number on the packaging; if you have these packs, contact a pharmacist or doctor and consider returning the product to the ph...

Actions Taken

The distribution of specified batches of Acurenal (quinapril), film-coated tablets, was suspended throughout the country and the decision was given immediate enforceability; the marketing authorisatio...

Need Help?

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

Related

Other Notices