Information about the recall of the batch 10714 B-2 of the medicinal product Bucain-Actavis 0.5% hyperbar (bupivacaine hydrochloride)
10.12.2013
The applicant for interventional import of the medicinal product Bucain-Actavis 0.5 % hyperbar (bupivacaine hydrochloride), Medika d.d., has, at the request of the Agency for Medicinal Products and Medical Devices (HALMED) initiated a recall of the batch 10714 B-2 of this product from the Croatian market.
The aforementioned batch entered the Croatian market through interventional import procedure and was distributed for use in hospital settings.
The recall procedure of this batch started after the 9 December 2013, when HALMED received a report to a suspected quality defect associated with a report to a suspected adverse reaction. The report to a suspected adverse reaction indicated a shortened duration of anaesthesia (20-30 min duration of blocks), independent from the dose and application technique, appearance of shudders, mild pain and uneasiness in arms after administration in four patients.
HALMED asked the Ministry of Health to sample the aforementioned product batch.
HALMED received neither a quality defect report to the medicinal product Bucain-Actavis 0.5 % hyperbar nor a report to the aforementioned adverse reactions to bupivacaine hydrochloride-containing medicinal products before.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
