Катрен Стиль
Производитель отзывает серию глюконата кальция в ампулах
Компания ФКП «Армавирская биофабрика» (Россия) приняла решение отозвать из обращения серию лекарственного препарата «Кальция глюконат» из‑за несоответствия качества по параметру «Описание». Информационное письмо об этом опубликовано 23 июля на сайте Росздравнадзора.
Речь идет о серии 530520 препарата «Кальция глюконат, раствор для внутривенного и внутримышечного введения, 100 мг/мл 10 мл, ампулы (10), пачки картонные». Гражданский оборот этой серии был прекращен в июне из‑за обнаружения экспертной организацией Росздравнадзора белого творожного осадка в некоторых ампулах.
С момента приказа Росздравнадзора все ЛС данной серии должны были находиться в зоне карантинного хранения. Теперь производители официально объявил о ее отзыве и аптека может вернуть упаковки «Кальция глюконата» этой серии поставщику. Об возврате надо обязательно сообщить в территориальный орган Росздравнадзора.
Ранее производители лекарственных препаратов «Политион» и «Омепразол» объявили об отзыве нескольких серий этих ЛС из‑за проблем с инструкциями. В упаковки «Омперазола» была вложена инструкция от другого препарата, а у серии «Политиона» инструкция отсутствует.
«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.
26 июля 2021
Фото: depositphotos.com
Выпуск: №211, июль 20211706 просмотров
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