Производители отзывают «Омепразол» и «Политион» из‑за проблем с инструкциями
Федеральная служба по надзору в сфере здравоохранения сообщает о решении производителей лекарственных препаратов «Политион» и «Омепразол» отозвать из обращения некоторые серии этих ЛС. Информационные письма об этом опубликованы 20 июля на сайте ведомства.
Компания АО «Новосибхимфарм» (Россия) отзывает из обращения серию 20421 препарата «Политион, концентрат для приготовления раствора для инфузий, 25 мг/мл 12 мл, ампулы (5), пачки картонные», поскольку в картонной пачке этого ЛС отсутствует инструкция по применению.
Кроме этого, компания ОАО «Синтез» (Россия) приняла решение отозвать серию 200421 лекарственного средства «Омепразол, капсулы кишечнорастворимые, 20 мг 10 шт., упаковки ячейковые контурные (3), пачки картонные». Во вторичную упаковку ЛС этой серии была помещена инструкция по применению для другого препарата — «Ацекардола».
Аптекам и другим субъектам обращения ЛС необходимо поместить указанные серии в изолированное хранение, чтобы не допустить их дальнейшего попадания в оборот.
Напомним, что ранее компания «Брынцалов-А» приняла решение отозвать из обращения две серии препарата «Этиловый спирт» из‑за отсутствия на упаковке обязательных КИЗ маркировки.
«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.
21 июля 2021
Фото: depositphotos.com
Выпуск: №211, июль 20212465 просмотров
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