Information about temporary distribution and application interruption of the one batch of the medicinal product Sandostatin LAR 30
03.08.2012
On 2 August 2012, the Agency for Medicinal Products and Medical Devices received a report from a health care professional about the quality defect of the medicine, Sandostatin LAR 30 mg, batch S0151. The report about the quality defect is related to the suspension reconstitution procedure, during which, instead of a milky suspension, clumpy clusters had occurred, due to which the medicine had not been used.
Novartis Hrvatska d.o.o., the marketing authorisation holder for the medicinal product Sandostatin LAR 30 mg, upon HALMED's request initiated on 3 August 2012 a distribution and application interruption of the application of the suspect batch of the medicinal product Sandostatin LAR 30 mg. The Ministry of Health took samples of the suspect batch and forwarded it to the Agency for testing.
The distribution and application interruption of the aforementioned batch of the medicinal product Sandostatin LAR 30 mg will be in effect until HALMED has completed the test results and additional safety evaluations, about which health care professionals and the general public will be promptly informed. There other batches of the same product available in the Croatian market that are not impacted by the aforementioned reporting and temporary distribution interruption.
The application interruption means that the aforementioned batch of the medicinal product is being kept in the site where observed until the test results and additional safety evaluations have been completed by HALMED and it is not returned to the distributor or marketing authorisation holder. Thereby the cold supply chain is not being at risk, in case HALMED decides to release again the same batch on the market.
Bearing in mind that the aforementioned quality defect is visible to the naked eye, due to which the reconstituted solution has not been used in patients, based on the available information, it is not considered that patients would be at risk, had the correctly reconstituted solution been applied to them.
Hereby, HALMED reminds all the health care professionals to strictly follow the instructions for preparation of this medicinal product in order to gain a uniform suspension that could be applied.
We remind that suspected quality defects of medicinal products should be reported to the Agency by using forms available here.
