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WARNING: RECALLED PRODUCT
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Mitomycin C Kyowa

Due to identified deviations in the manufacturing process of the active substance, it cannot be ensured that the medicinal products made from it meet sterility specification requirements. The authority points to a potential direct threat to patients’ health or life. Potential effects: infection, severe post-injection complications, risk to health or life.

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Mitomycin C Kyowa
Risk Level
Critical
Manufacturer
Nordic Pharma s.r.o. Czechy
Batch Number
013AFL02
EAN Code
05909990098217
Recall Date
25.10.2019
View official statement

Important Information

What You Should Know

Recommendations

Do not use the product batches covered by the decision. Check the batch number of any product held; if affected, return it to the pharmacy or consult a physician. In case of doubt or adverse effects, ...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of the medicinal product from the entire national market and granted the decision immediate enforceability; the marketing authorisatio...

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: Due to identified deviations in the manufacturing process of the active substance, it cannot be ensured that the medicinal products made from it meet sterility specification requirements. The authority points to a potential direct threat to patients’ health or life. Potential effects: infection, severe post-injection complications, risk to health or life.
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?
Affected batch numbers: 013AFL02

Related

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