Катрен Стиль
Из обращения отозвано 40 серий спрея «Ксилен НЕО» (список)
Компания ООО «ВЕРОФАРМ» сообщает об отзыве из обращения нескольких десятков серий своего препарата «Ксилен НЕО» из‑за выявленных несоответствий качества. Информационное письмо об этом опубликовано 16 сентября на сайте Росздравнадзора.
Речь идет о лекарственном препарате «Ксилен НЕО, спрей назальный с ароматом камфоры и ментола 0.1 % 15 г, флаконы (1), пачки картонные» серий:
11018, 21018, 31018, 41018, 51118, 61118, 71118, 81118, 91118, 101118, 111118, 121118, 131218, 10119, 20119, 30119, 50219, 60219, 70319, 80319, 90319, 100319, 110319, 120319, 130319, 140319, 150319, 160419, 170419, 180419, 190419, 200419, 210419, 220419, 230419, 240419, 250419, 270419, 280419, 290419.
Причиной для такого масштабного отзыва является несоответствие качества указанных серий требованиям нормативной документации по показателю «Родственные примеси». Ранее из‑за этого Росздравнадзор прекратил обращение двух серий спрея. Теперь производитель объявил о решении изъять из обращения и другие серии ЛС, не отвечающие положенным требованиям.
Росздравнадзор напоминает, что, согласно пункту 30 Правил надлежащей практики хранения и перевозки, препараты, обращение которых приостановлено, или лекарственные средства, возвращенные производителю, должны быть помещены в отдельное помещение (зону) или изолированы с применением системы электронной обработки данных, обеспечивающей разделение, чтобы не допустить их реализацию.
«Катрен-Стиль» ежемесячно публикует обзоры информационных писем Росздравнадзора, посвященных отзыву и изъятию ЛС, а также последним изменениям в ГРЛС. Большое количество данных в таких статьях организовано в виде таблиц — по ним удобно проверять свой ассортимент на наличие «карантинных» или лишившихся регистрации препаратов. Последний обзор с перечнем таких ЛС читайте по этой ссылке.
17 сентября 2020
Фото: depositphotos.com
Выпуск: №200, сентябрь 20201685 просмотров
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