Konaten

Q: Is this product safe to consume?

No. This product has been recalled due to: Out-of-specification (OOS) results were found in reference samples for atomoxetine content, below the lower specification limit; for one batch also non-compliance in capsule mass uniformity; the impact on safety was assessed as low. Potential effects: reduced treatment effectiveness, possible worsening of symptoms, risk of complications due to poor disease control.

Q: Which batches are affected?

Affected batch numbers: 1111121

Out-of-specification (OOS) results were found in reference samples for atomoxetine content, below the lower specification limit; for one batch also non-compliance in capsule mass uniformity; the impact on safety was assessed as low. Potential effects: reduced treatment effectiveness, possible worsening of symptoms, risk of complications due to poor disease control.

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Risk Level

Medium

Manufacturer

neuraxpharm Arzneimittel GmbH z siedzibą w Niemczech

Batch Number

1111121

EAN Code

05909991390938

Recall Date

28.08.2024

What You Should Know

Recommendations

Do not use the product from the listed batches. Patients should check the batch number on the pack, return any affected product to the pharmacy, and consult a doctor or pharmacist about the need for a...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Konaten (Atomoxetine) from the market nationwide, prohibited their placing on the market, and granted the decision immediate enforc...

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: Out-of-specification (OOS) results were found in reference samples for atomoxetine content, below the lower specification limit; for one batch also non-compliance in capsule mass uniformity; the impact on safety was assessed as low. Potential effects: reduced treatment effectiveness, possible worsening of symptoms, risk of complications due to poor disease control.

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: 1111121

Konaten

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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