Israel Recalls Specific Drug Batch Due to Rare Hypersensitivity Reactions
Translated & summarized from Cursorinfo by baba
Israel's Ministry of Health and distributor Medici Medical are voluntarily recalling a specific batch of Flebogamma 5% DIF due to an increased incidence of hypersensitivity reactions. Other batches remain safe for use, and alternative treatments are available. The recall affects distribution channels from pharmacies to warehouses, with procedures in place for returning the affected product for compensation.
The story in 5 lines · by baba
- Israel's Ministry of Health and Medici Medical recalled a specific batch of Flebogamma 5% DIF.
- The recall is due to an unusually high frequency of hypersensitivity reactions reported.
- All other batches of the drug remain safe and available for patient use.
- The recall is a precautionary measure, and alternative treatments are available.
- The affected batch must be returned to the "Sosna" trading house for compensation.
Israel's Ministry of Health and Medici Medical, the local distributor, announced on Wednesday evening the voluntary recall of a specific batch of the medication Flebogamma 5% DIF. The recall was initiated after several reports of an unusually high frequency of hypersensitivity reactions among patients who received this particular batch. The decision was made jointly by the ministry and the company as a precautionary measure.
While the affected batch is being removed from circulation, all other batches of Flebogamma 5% DIF available in Israel have been deemed safe for use, and patients can continue receiving them as usual. The ministry emphasized that alternative treatments are available in the Israeli market, which facilitated the decision to withdraw the problematic series.
The recall is classified as Category II, affecting customers, pharmacies, hospital clinics, and commercial warehouses. Any medical institutions or suppliers holding stock from the recalled batch must immediately cease its distribution, move the packages to a designated quarantine area, and return them to the "Sosna" trading house for compensation. Instructions regarding the recall must also be disseminated to all relevant personnel.
Flebogamma 5% DIF, manufactured by GRIFOLS, is an intravenous medication containing human antibodies (immunoglobulins). It is used for replacement therapy in patients with primary or secondary immunodeficiency, where the body does not produce enough antibodies. It is also prescribed to regulate the immune system in autoimmune and inflammatory conditions such as ITP, Guillain-Barré syndrome, and Kawasaki disease, helping to prevent the body from attacking its own tissues.
