Катрен Стиль
Производитель отзывает серию сиропа от аллергии
Федеральная служба по надзору в сфере здравоохранения сообщает о принятом компанией ООО «ШЛС Фарма» решении отозвать из обращения серию лекарственного препарата «Кларидол» (лоратадин). Информационное письмо об этом опубликовано 6 апреля на сайте ведомства.
Речь идёт о препарате «Кларидол, сироп, 1 мг/мл 100 мл, флаконы тёмного стекла (1), пачки картонные» серии ELR012001 производства «Шрея Лайф Саенсиз Пвт. Лтд» (Индия). Отзыв связан с необходимостью внести изменения в регистрационное досье на этот препарат. Какие именно изменения будут добавлены в досье, производитель не уточняет.
При обнаружении этой серии в своём ассортименте аптекам необходимо предоставить в территориальный орган Росздравнадзора сведения, подтверждающие возврат ЛС поставщикам или производителю.
Ранее компания «Опелла Хелскеа Франс САС» объявила об отзыве 38 серий препарата «Фосфалюгель» из‑за превышения допустимой суточной нормы содержания свинца.
«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.
7 апреля 2022
Фото: depositphotos.com
Выпуск: №220, апрель 20221858 просмотров
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1858 просмотров
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