Катрен Стиль
Очередной ранитидин отзывают из обращения
Росздравнадзор информирует о принятом ОАО «Ирбитский химико-фармацевтический завод» решении отозвать из оборота серию препарата «Ранитидин» из‑за приостановки действия сертификата пригодности на субстанцию, из которой изготовлен препарат. Информационное письмо об этом опубликовано 9 октября на сайте ведомства.
Отзыву подлежит серия 30219 препарата «Ранитидин, таблетки покрытые оболочкой 150 мг 10 шт., упаковки ячейковые контурные (2), пачки картонные». Причиной для отзыва служит решение Специального комитета Европейского директората по качеству медицинской продукции (EDQM) о приостановлении сертификата пригодности на субстанцию «Ранитидина гидрохлорид» производства «Сарака Лабораториз Лимитед».
Напомним, что в субстанции этого производителя были обнаружены примеси N-нитрозодиметиламина (NDMA).
Ранее из оборота были отозваны другие препараты, изготовленные из этой индийской фармсубстанции: «Зантак» и «Ранитидин» производства ««Хемофарм А. Д. Вршац».
По информации Росздравнадзора, в настоящий момент идет проверка образцов препаратов ранитидина, находящихся в российском обороте, на предмет наличия в них потенциально канцерогенных примесей NDMA. Кроме этого, ведомство подготовило рекомендации для производителей ЛС по выявлению этих примесей в субстанциях и готовых лекарственных препаратах.
Напомним, что «Катрен-Стиль» на основе информации Росздравнадзора регулярно составляет списки изъятых из обращения препаратов. Перечень ЛС, отозванных в сентябре, смотрите в статье «Убираем в карантин».
11 октября 2019
Фото: depositphotos.com
Выпуск: №189, октябрь 20195086 просмотров
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