Corhydron 25

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.

An out-of-specification (OOS) result was found in stability testing for the free hydrocortisone content; further increase is expected until the end of shelf life of batch 110021, which may affect dissolution and the drug’s performance. Potential effects: reduced therapeutic efficacy or unpredictable effects of the injectable medicine.

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Corhydron 25
Risk Level
Critical
Manufacturer
Bausch Health Ireland Limited z siedzibą w Dublinie, Irlandia
Batch Number
110021
Notice Date
18.09.2024
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 Corhydron 25 from batch 110021 (expiry 09.2024); check the batch number on the packaging, return any packs from this batch to a pharmacy, and consult a doctor if in doubt.

Actions Taken

Withdrawal of batch 110021 of the medicinal product Corhydron 25 from the market throughout the country; prohibition of placing this batch on the market; the decision was given immediate enforceabilit...

Need Help?

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

Related

Other Notices