Vendal Stechampullen

In a letter dated May 26, 2014, the marketing authorization holder informed its customers that the degree of discoloration of batch 2G605A is just outside the permitted limit and the impurities are elevated. For batch 2M631A, although the degree of discoloration is within the allowed limit, the measured value for impurity B is 0.7%, which is above the allowed limit of 0.5%. Batch 3F639A is currently within specifications, but is also being recalled as a precaution due to its expiration date of 06/2015.

As this is a product containing narcotics, we request appropriate documentation of the return delivery and the receipt of the replacement goods.

Further inquiry note

am-qualitaetsmangel@basg.gv.at