Катрен Стиль
Производитель отзывает серию этилового спирта из‑за путаницы с этикетками
Компания «Гиппократ» сообщает об отзыве из обращения серии лекарственного препарата «Этиловый спирт» из‑за использования этикеток из двух разных партий. Информационное письмо об этом опубликовано 18 января на сайте Росздравнадзора.
Речь идёт о серии 060619 лекарственного препарата «Этиловый спирт, концентрат для приготовления раствора для наружного применения 95 % 100 мл, флаконы тёмного стекла (50), ящики картонные». При производстве этого ЛС на предприятии были использованы этикетки из разных партий, имеющие существенные различия в размещении данных штрих-кода и шрифте номера серии и срока годности.
Из-за этих различий обращение серии 060619 было приостановлено Росздравнадзором в сентябре прошлого года, поскольку специалисты ФГБУ «ИМЦЭУАОСМП» Казанского филиала Росздравнадзора посчитали это признаками фальсификации.
Аптекам и другим субъектам обращения ЛС необходимо поместить указанную серию в изолированное хранение, чтобы не допустить её попадания в оборот. Производителю предписано в срок до 8 февраля предоставить в Росздравнадзор сведения об изъятии из обращения серии 060619.
Ранее производитель лекарственного препарата «Алмагель» объявил об отзыве из обращения 26 серий ЛС. Причиной этому стало прекращение действия деклараций о соответствии.
«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.
19 января 2021
Фото: depositphotos.com
Выпуск: №204, январь 20212551 просмотров
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