Possible High Levels Of Active Ingredient Leads To Class 1 Recall

All remaining stock of four batches of Oxybutynin Hydrochloride 5mg tablets is being recalled by Niche Generics Ltd due to the possibility they could contain too much of the active ingredient.

Oxybutynin Hydrochloride is often sold as a generic product and as such, is not always associated with a brand name. It is used to treat bladder conditions such as urinary incontinence and would most likely be taken by children with an uncontrollable nocturnal bladder, or by the elderly.

The Medicines and Healthcare products Regulatory Agency (MHRA) understands high levels of the active ingredient have been found during early stages of production but may not have reached the finished tablet. However, all stock is being recalled as a precautionary measure while an investigation is underway.

Both Niche Generics Ltd and Actavis UK Ltd have supplied the Oxybutynin Hydrochloride 5mg tablets and both companies are urging patients to contact their pharmacist or healthcare professional so they can have their medication replaced with stock from an unaffected batch.

The affected batches are:

Livery  Batch No        Expiry Date     Pack Size       First Distributed      
Niche   09D02   12/2011 84      16/04/2009     
Niche   09D04   12/2011 84      16/04/2009     
Actavis 146401  12/2011 56      05/05/2009     
Actavis 146402  12/2011 56      22/05/2009     

SOURCE: Medicines and Healthcare products Regulatory Agency