Seronil

Q: Is this product safe to consume?

No. This product has been recalled due to: It was found that in batches 2127580 and 2132779 the level of the impurity N-nitroso fluoxetine exceeds the temporary limit acceptable to EMA, which means loss of the required quality of the medicine and a potential risk to human health. Potential effects: possible carcinogenic effects with long-term use, impaired treatment efficacy.

It was found that in batches 2127580 and 2132779 the level of the impurity N-nitroso fluoxetine exceeds the temporary limit acceptable to EMA, which means loss of the required quality of the medicine and a potential risk to human health. Potential effects: possible carcinogenic effects with long-term use, impaired treatment efficacy.

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Risk Level

High

Manufacturer

Orion Corporation

Batch Number

2127580

Recall Date

14.08.2025

What You Should Know

Recommendations

Do not use Seronil 20 mg from batches 2127580 and 2132779. Check the batch number on the packaging; if you possess these batches, return the product to a pharmacy and consult your doctor or pharmacist...

Actions Taken

The Chief Pharmaceutical Inspector withdrew Seronil 20 mg hard capsules batches 2127580 and 2132779 from the entire national market, prohibited their placing on the market, and granted the decision im...

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: It was found that in batches 2127580 and 2132779 the level of the impurity N-nitroso fluoxetine exceeds the temporary limit acceptable to EMA, which means loss of the required quality of the medicine and a potential risk to human health. Potential effects: possible carcinogenic effects with long-term use, impaired treatment efficacy.

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.

Seronil

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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