Lorabex

Q: Is this product safe to consume?

No. This product has been recalled due to: Suspected quality defect: out-of-specification (OOS) results for the parameters Lorazepam content and Lorazepam related substances, which may indicate an incorrect amount of active substance and impurities in the solution for injection. Potential effects: lack of treatment efficacy, excessive sedative effect, adverse reactions, complications.

Suspected quality defect: out-of-specification (OOS) results for the parameters Lorazepam content and Lorazepam related substances, which may indicate an incorrect amount of active substance and impurities in the solution for injection. Potential effects: lack of treatment efficacy, excessive sedative effect, adverse reactions, complications.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne „Polpharma” S.A., ul. Pelplińska 19, 83-200 Starogard Gdańsk

Batch Number

A905BB

EAN Code

05903060621237

Recall Date

16.02.2023

What You Should Know

Recommendations

Do not use the product from batch A905BB; patients who have this medicine should consult a doctor or pharmacist regarding further treatment and possible return of the packs to a pharmacy.

Actions Taken

The distribution of batch A905BB of Lorabex 4 mg/ml, solution for injection, has been suspended throughout the country, with the decision given immediate enforceability; the marketing authorisation ho...

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: Suspected quality defect: out-of-specification (OOS) results for the parameters Lorazepam content and Lorazepam related substances, which may indicate an incorrect amount of active substance and impurities in the solution for injection. Potential effects: lack of treatment efficacy, excessive sedative effect, adverse reactions, complications.

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: A905BB

Lorabex

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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