Osporil – one batch of prescription drug suspended from circulation. GIF decision

The Chief Pharmaceutical Inspector announced the suspension of trade in the medicinal product called:

Osporil (Zoledronic acid), 4mg/100mlinfusion solution, packaging 1 vial 100 mlGTIN 05909991228392within the following series: series number: ZD033the term of validity: 03.2026.

The responsible entity is Egis Pharmaceuticals PLC with its registered office in Budapest, Hungary.

GIF made the decision immediately enforceable.

As we read in the GIF justification, at the end of July 2024, the Chief Pharmaceutical Inspectorate received information from the National Institute of Medicines about a study conducted for the medicinal product Osporil.

“It was indicated that this product does not meet the quality requirements specified for it due to the negative test result for the parameter appearance of the solution. The National Institute of Medicines found in the batch of the medicinal product in question the presence of particles visible to the naked eye,” it was emphasized.

“The reason for suspending trade in a medicinal product is therefore a reasonable suspicion that the product does not meet the requirements established for it,” GIF emphasized.

GIF added that any exceedance of the parameters must be considered a circumstance constituting a real and direct threat to the health or life of patients – until the reason for the deviation is clearly identified and it is proven that it does not constitute such a threat.

The active substance in Osporil is zoledronic acid, which belongs to a group of medicines called bisphosphonates. Zoledronic acid works by attaching to bone tissue and slowing down the rate of bone turnover. It is used to prevent bone complications, such as fractures, in adult patients with bone metastases and to reduce the level of calcium in the blood of adult patients when the level is high due to the presence of a tumour.