The marketing authorization holder informed its supplied customers in a letter dated September 15, 2011, that crystalline particles may be present in the amino acid chamber of the three batches mentioned and that a recall is therefore being carried…

The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by fax dated September 14 that all batches of Vimpat Syrup are being recalled. The reason for this recall is precipitation…

The marketing authorization holder informed its supplied customers in a letter dated 07.09.2011 that due to individual reports of an unpleasant, moldy odor, a further batch must be recalled. This odor emanates from the primary packaging (plastic…

The distribution company has informed its supplied customers by letter dated August 29, 2011, that the batches indicated above may be contaminated with particles and are therefore recalled as a precautionary measure.

The marketing authorization holder has informed its supplied customers by letter dated 23.08.2011 that a replacement will be carried out due to crystallization of the calcium solution. Note: On 06.06.2011, the batches L108003 and L118002 were already…

The marketing authorization holder informed its supplied customers in a letter dated August 12, 2011, that individual tablets may break when they are pressed out of the blister and that this batch will therefore be replaced.

The marketing authorization holder informed its supplied customers in a letter dated August 9, 2011, that the release of the active ingredient may be accelerated in the three batches mentioned and that a replacement will therefore be carried out as a…

The marketing authorization holder informed its supplied customers in a letter dated July 7, 2011, that another batch that had exceeded the 18-month shelf life would be replaced. Already on April 12, 2011, batches were withdrawn from the market after…

In a letter dated July 13, 2011, the marketing authorization holder informed its supplied customers that, in addition to the tablets, glass splinters may also be present in the amber glass vials. These particles are caused by chipping of the bottle…

In a letter dated July 7, 2011, the marketing authorization holder informed its customers that stability tests had revealed that the active ingredient content had been exceeded and that the batch concerned would therefore be replaced as a…