Производитель отзывает серию антибиотика из‑за вздутия блистеров
Росздравнадзор сообщает о решении компании ООО «ФармКонцепт» отозвать из оборота серию препарата «Циклосерин» из‑за дефекта первичной упаковки ЛС. Информационное письмо об этом опубликовано 22 июня на сайте ведомства.
Отзыву подлежит серия 0090919 препарата «Циклосерин, капсулы 250 мг 10 шт., упаковки ячейковые контурные (10), пачки картонные» производства ООО «ФармКонцепт» (Россия). Проверка установила вздутие фольги на блистерах препарата.
Всем субъектам обращения лекарственных средств необходимо провести проверку наличия указанных серий в своём ассортименте и при обнаружении переместить их в карантин.
В апреле прошлого года Росздравнадзор приостановил реализацию другой серии «Циклосерина» производства «ФармКонцепт». Тогда в блистерах препарата были обнаружены капсулы разного размера.
Ранее компания ООО «Эллара» объявила об отзыве десяти серий препарата «Мексидол» из‑за нечитаемой маркировки на упаковках ЛС.
«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.
23 июня 2021
Фото: depositphotos.com
Выпуск: №209, июнь 20211985 просмотров
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