28 March 2019
The Rigvir Group has conducted a series of drug tests and found several batches that do not conform with the specification. Sales of the specific batches have been halted in a timely manner. There has been no risk to the health and safety of patients, but a minor and short-term potential effect on therapeutic efficacy for a small number of vials has been identified.
The in-house investigation showed that there is no doubt and risk with regard to the safety, stability or other aspects of Rigvir that could result from the nature and characteristics of the virus. It has been found that the non-compliance of the product with the specification is linked to a set of external conditions, incl. storage conditions. All shortcomings are eliminated in short term in cooperation with competent authorities.
Recently, inaccurate and misrepresenting information on the tests carried out by an independent laboratory has been reported. The Rigvir group emphasise that these results were obtained using different cells, unvalidated methods and are not objectively comparable. Rigvir tests are performed regularly by a validated method at the WHO Reference Laboratory with a validated method. To make sure that public information is true and in case of questions or uncertainties, please contact the Rigvir group directly: firstname.lastname@example.org.