Росздравнадзор прекратил оборот серии кардиотонического препарата
22 апреля 2022
Фото: depositphotos.com
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№220, апрель 2022
2346 просмотров
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.jpg)
Росздравнадзор прекратил оборот серии кардиотонического препарата
Федеральная служба по надзор в сфере здравоохранения сообщает о прекращении обращения серии лекарственного препарата «Дигоксин» (МНН: дигоксин). Информационное письмо об этом опубликовано 21 апреля на сайте ведомства.
Речь идёт о препарате «Дигоксин, таблетки, 0,25 мг 10 шт., упаковки ячейковые контурные (3), пачки картонные» серии 030920 производства АО «Усолье-Сибирский химфармзавод» (Россия). В рамках выборочного контроля качества у этой серии было выявлено несоответствие нормативной документации по показателю «Растворение».
Прекращение оборота означает, что всем субъектам обращения ЛС, включая медицинские организации, необходимо провести проверку наличия этой серии и при обнаружении поместить её в карантинное хранение. В дальнейшем производитель может инициировать её отзыв или Росздравнадзор сообщит о решении возобновить её обращение.
Ранее производитель офтальмологического препарата «Эмоксипин» принял решение отозвать из оборота одну серию этого ЛС из‑за обнаруженных во флаконах осколков стекла.
«Катрен-Стиль» регулярно публикует обзоры информационных писем Росздравнадзора, посвящённых отзыву и изъятию ЛС, а также списки препаратов, лишившихся регистрации в течение месяца. Большое количество данных в таких статьях организовано в виде таблиц — по ним удобно проверять свой ассортимент на наличие таких ЛС. Последний обзор с перечнем таких ЛС читайте по этой ссылке.
Катрен Стиль
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