Urgent drug recall in Israel — unusual side effects (PHOTO)
The Israeli Ministry of Health and Medicus Medical have announced a voluntary recall of a specific batch of Flebogamma 5% DIF (manufactured by GRIFOLS) due to unusual side effects. The recall is limited to this batch, with others deemed safe. The decision follows reports of an increased frequency of hypersensitivity reactions.
The Israeli Ministry of Health and Medicus Medical, the drug supplier, announced on Wednesday evening a voluntary market recall of a specific batch of the medication Flebogamma 5% DIF (manufactured by GRIFOLS). The cause was unusual side effects — several reports of an increased frequency of hypersensitivity reactions in patients who received the drug from this particular batch. The recall is being conducted as a precautionary measure; alternative treatment options are available on the market. Other batches of the drug are deemed safe and their use can continue. The recall is classified as Category II — at the level of customers, pharmacies, hospital clinics, and commercial warehouses. Packages from the problematic batch must be moved to quarantine and returned to the trading house "Sosna" for compensation. The drug contains immunoglobulins and is used for primary or secondary immunodeficiency, as well as autoimmune diseases including ITP, Guillain-Barré syndrome, and Kawasaki disease.