Tetmodis

Q: Is this product safe to consume?

No. This product has been recalled due to: Out-of-specification results were found for active substance content in batch T1702PL of Tetmodis (Tetrabenazine), which may mean an inappropriate dose for the patient. Potential effects: lack of efficacy or increased adverse effects.

Q: Which batches are affected?

Affected batch numbers: T1702PL

Out-of-specification results were found for active substance content in batch T1702PL of Tetmodis (Tetrabenazine), which may mean an inappropriate dose for the patient. Potential effects: lack of efficacy or increased adverse effects.

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Risk Level

Medium

Manufacturer

AOP Orphan Pharmaceuticals AG, Austria

Batch Number

T1702PL

EAN Code

05909990805594

Recall Date

26.02.2020

What You Should Know

Recommendations

Do not use Tetmodis from batch T1702PL, check the batch number on the packaging, and if you have this batch, return it to the pharmacy; if you have any doubts or symptoms, contact a doctor.

Actions Taken

Withdrawal of Tetmodis batch T1702PL from the market throughout the country and granting the decision immediate enforceability; the marketing authorisation holder was obliged to carry out the withdraw...

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 results were found for active substance content in batch T1702PL of Tetmodis (Tetrabenazine), which may mean an inappropriate dose for the patient. Potential effects: lack of efficacy or increased adverse effects.

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: T1702PL

Tetmodis

What You Should Know

Recommendations

Actions Taken

Need Help?

Frequently Asked Questions

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