Катрен Стиль
Прекращён оборот серии парацетамола из‑за проблем с растворением
Федеральная служба по надзору в сфере здравоохранения приняла решение прекратить обращение серии препарата «Парацетамол Велфарм» из‑за её несоответствия требованиям качества. Информационное письмо об этом опубликовано 8 июля на сайте регулятора.
С 7 июля прекращён гражданский оборот лекарственного средства «Парацетамол Велфарм, таблетки, 500 мг 10 шт., упаковки ячейковые контурные (2), пачки картонные» серии 141020 производства ООО «Велфарм» (Россия). Причиной для этого является несоответствие показателю «Растворение», указанному в нормативной документации на препарат. Это было выявлено в рамках фармаконадзора — выборочного контроля качества ЛС, проводимого Росздравнадзором.
Всем субъектам обращения ЛС — аптекам, медицинским организациями и оптовым поставщикам — необходимо провести проверку наличия этой серии в своём ассортименте и при обнаружении сообщить в территориальный орган Росздравнадзора. Региональным отделениям ведомства поручено обеспечить изъятие и уничтожение этой недоброкачественной серии.
Ранее Росздравнадзор сообщил о прекращении оборота серии препарата «Рамиприл» из‑за несоответствия показателю «Родственные примеси».
Напомним, что «Катрен-Стиль» регулярно публикует обзоры информационных писем Росздравнадзора, посвящённых отзыву и изъятию ЛС, а также списки препаратов, лишившихся регистрации в течение месяца. Последний обзор с перечнем таких ЛС читайте по этой ссылке.
11 июля 2022
Фото: © Subbotina / Фотобанк Фотодженика
Выпуск: №223, июль 20221197 просмотров
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1197 просмотров
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