Катрен Стиль
Из оборота отозвано более 20 серий препарата с ципрофлоксацином
Федеральная служба по надзору в сфере здравоохранения сообщает о решении компании «Тева» отозвать из гражданского оборота 21 серию противомикробного препарата «Ципрофлоксацин-Тева». Информационное письмо об этом опубликовано 5 мая на сайте ведомства.
Речь идёт о следующем ЛС: «Ципрофлоксацин-Тева, таблетки, покрытые плёночной оболочкой, 500 мг 10 шт., блистеры (1), пачки картонные» серий 4490620, 4500620, 4561120, 4571120, 4620121, 4630121, 4610121, 4600121, 4650521, 4680521, 4670521, 4660521, 4690521, 4730921, 4710921, 4720921, 4770622, 4790622, 4780622, 4800622, 4820622 производства «Тева Фармасьютикал Воркс Прайвэт Лимитед Компани» (Венгрия).
Причиной для отзыва является превышение содержания промежуточного предела примеси N-нитрозо-ципрофлоксацина при проведении тестирования ряда серий этого ЛС.
При обнаружении какой‑либо из указанных серий препарата аптекам и медицинским учреждениям следует вернуть её поставщику (производителю) и предоставить в территориальный орган Росздравнадзора подтверждающие это сведения.
«Катрен-Стиль» ежемесячно составляет перечень лекарственных средств, оборот которых был прекращён Росздравнадзором, а также препаратов, которые были отозваны производителями или лишены государственной регистрации. Последний обзор информационных писем регулятора со списком таких ЛС читайте по этой ссылке.
10 мая 2023
Фото: © Aliaksandr Zadoryn (istockphoto.com)
Выпуск: №233, май 20232053 просмотров
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2053 просмотров
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