Trazodone Neuraxpharm

Q: Is this product safe to consume?

No. This product has been recalled due to: An out-of-specification (OOS) result was recorded for the tablet hardness parameter, potentially linked to different blister foils and gas permeability, which could affect product hardness during storage. Potential effects: possible changes in active substance release, altered bioavailability and efficacy, although the investigation showed no significant impact.

Q: Which batches are affected?

Affected batch numbers: P2200932

An out-of-specification (OOS) result was recorded for the tablet hardness parameter, potentially linked to different blister foils and gas permeability, which could affect product hardness during storage. Potential effects: possible changes in active substance release, altered bioavailability and efficacy, although the investigation showed no significant impact.

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Risk Level

Low

Manufacturer

Neuraxpharm Arzneimittel GmbH z siedzibą w Langenfeld, Niemcy

Batch Number

P2200932

EAN Code

05909991373290

Recall Date

10.01.2024

What You Should Know

Recommendations

Patients may use the medicine as prescribed; if they have any doubts or notice irregularities in the tablets, they should consult their doctor or pharmacist.

Actions Taken

The marketing of the specified batches was suspended, an investigation was conducted, the withdrawal procedure was discontinued, and then the decision to suspend marketing was declared expired as moot...

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: An out-of-specification (OOS) result was recorded for the tablet hardness parameter, potentially linked to different blister foils and gas permeability, which could affect product hardness during storage. Potential effects: possible changes in active substance release, altered bioavailability and efficacy, although the investigation showed no significant impact.

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: P2200932

Trazodone Neuraxpharm

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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