Israel Recalls Myasthenia Gravis Drug Due to Glass Particle Contamination
Israel's Ministry of Health and Johnson & Johnson have announced the recall of the drug IMAAVY, used to treat generalized myasthenia gravis in adults and adolescents aged 12 and older. The recall, classified as a Level 2, affects specific batches of the medication distributed through hospitals and clinics. Johnson & Johnson, the drug's distributor in Israel, initiated the withdrawal after the discovery of glass particles, a result of the manufacturing process, in some product units.
The Ministry of Health has instructed all organizations possessing the affected batches to cease their use immediately, isolate the product, and return it to the distributor, SLA, for a credit. IMAAVY is prescribed to patients with antibodies to acetylcholine receptors or muscle-specific tyrosine kinase and is available by prescription through pharmacies, hospitals, and clinics.
The primary risk to patients from the recalled batches is the potential for microscopic glass particles to enter the bloodstream. However, medical professionals have reassured the public that a shortage of the drug in the Israeli market is not anticipated following this recall.
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