27 March 2008
This is to inform you that UCB is recalling certain batches of Neupro® (rotigotine transdermal patches) as a result of a manufacturing issue.
Neupro® is indicated for the treatment of the signs and symptoms of early and advanced stage idiopathic Parkinson’s disease and is distributed by Schwarz Pharma, a company of UCB Group.
The global recall will cause an out-of-stock situation of Neupro® in the United States. However, please be reassured that Neupro® supply is sufficient in the UK and the rest of the European Union.
An issue relating to the manufacturing of Neupro® (rotigotine transdermal patch) has resulted in an unexpected visual appearance of some patches, resembling snowflakes (see example picture on reverse). This visual appearance is of no clinical relevance as long as the product meets approved specification. In the European Union, patches other than those of the recalled batches are within the approved specification.
It is important to emphasise that the issue is not one of product contamination or toxicity but rather one of possibly reduced efficacy of some patches. If a significant area of the patch is affected by the snowflake formation, the clinical performance of the product cannot be assured. We are bringing this to your attention so that you are in position to respond to inquiries that you may receive.
It is important that patients do not suddenly stop taking Neupro®, as this may cause adverse effects. If a patient is concerned about snowflakes or any other issue related to their Neupro® therapy, they should speak to their doctor.
If you or your members have any questions, please contact UCB Medical Information on 01753 534655.
Thank you for your understanding and assistance.
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On the 2nd April a letter to GP’s, Retail and Hospital Pharmacists, Neurologists and Geriatricians is also being distributed.
