One batch of the “Rovatineks” has been recalled

One batch of the “Rovatineks” has been recalled

According to the application letter No. 3-28-1/1-29929/2024 of the company “Girkhbulaq” LLC dated 20.12.2024, the marketing authorization holder of the “Rovatineks” drug with the trade name capsules No. 50 (5×10) in aluminum foil blister, cardboard box packaging, batch number 8481C, expiration date 12/2025, obtained out-of-specification results after stability studies conducted by the manufacturer: during the 36-month stability studies of the drug, it was found that the olive oil present as an excipient had a non-specific odor and the peroxide value increased as a result of the analysis. Due to this quality defect, the manufacturer stated that it intends to voluntarily recall the drug in the Republic of Azerbaijan. It was stated that the recall class of the mentioned medicinal product was determined as 3 (cases where the medicinal product does not pose a direct threat to the life and health of the person), and the recall level of the medicinal product was determined as “B” (up to the enterprises providing the end user with the medicinal product (retail establishment, medical establishment)).

Based on the above, a decision was made to recall the medicinal product “Rovatinex capsules No. 50”, batch number 8481C, expiration date 12/2025, belonging to the Irish marketing authorization holder “Rowa Pharmaceuticals LTD”. This means that only the medicinal product with the series 8481C, expiration date 12/2025 is recalled.

We would like to inform you that stability studies are conducted to study the shelf life of the medicinal product was carried out in special stability chambers with temperature and humidity indicators different from normal conditions. The letter states that, despite this, the manufacturer has not received any complaints regarding the drug in question.