Information on recall of one batch of Lybrol 1.25 mg tablets (bisoprolol)
"Jadran" - Galenski laboratorij d.d. company which is the marketing authorisation holder for Lybrol medicinal product, has informed the Agency for Medicinal Products and Medical Devices (HALMED) on recall of one batch of Lybrol 1.25 mg tablets. The batch Nr 16083D is being withdrawn from tha market due to a quality defect detected during the stability testing of the product.
The results of the testing demonstrate a higher content of the degradation product of the active substance, the impurity L, within the shelf-life with regard to the product specification. A lower content of the active substance within the shelf-life with regard to the product specification has also been identified. The shelf-life of the recalled batch is April 2012. A toxicological assessment has been performed and a risk for patients has been estimated. It has been concluded that the content of the impurity L is bellow the acceptable daily dose and therefore does not represent a toxicological risk for patients. Upon the information to wholesalers, the product is being withdrawn, accordingly.