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Direct Healthcare Professional Communication (DHPC) on Cystagon 150 mg of the company Recordati Rare Diseases: Recall of batch T2208

Active substance: Mercaptamine bitartrate

Recordati Rare Diseases informs about a precautionary recall of batch T2208 of the medicinal product Cystagon 150 mg capsules. Eight reports of hospitalisation for severe gastrointestinal symptoms in Turkey have been received for this batch where excessive strong odour of the capsules was noted. There have also been reports of excessive odour and broken capsules in other batches. The investigation covering the affected batches has not identified any quality defect.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 347KB, File is accessible