Ministry of Health Announces Voluntary Recall for Flebogamma Batch
Israel's Ministry of Health and Medici Medical have announced a voluntary recall for a specific batch of Flebogamma 5% DIF due to reports of unusual hypersensitivity side effects.
The Ministry of Health and Medici Medical, the distributor of the product in Israel, announced a voluntary recall of a specific batch of the medication due to unusual side effects. All other batches remain safe for regular use.
The recall decision was made jointly following several reports of hypersensitivity reactions occurring at a higher frequency than usual among patients treated with this specific batch. Authorities stressed that other batches currently marketed in Israel are fully functional and safe.
The recall is classified as a Class II level, targeting pharmacies, clinics, hospitals, and commercial warehouses. Facilities possessing the affected batch are instructed to immediately halt dispensing, isolate the stock, and return it to the "Susanna" trading house for a refund.
The recalled product is Flebogamma 5% DIF by GRIFOLS, an intravenous preparation containing human immunoglobulins used as replacement therapy for primary or secondary immunodeficiencies, as well as for immunomodulation in autoimmune and inflammatory diseases.
