Катрен Стиль
Производитель отзывает 4 серии препаратов от гипертензии
Росздравнадзор сообщает о решении компании «Озон» прекратить действие деклараций о соответствии одной серии препарата «Лизиноприл» и трех серий препарата «Метопролол» из‑за нарушений маркировки первичной упаковки. Также эти серии ЛС подлежат изъятию из оборота. Письмо об этом опубликовано 16 марта на сайте ведомства.
Отзыву из обращения подлежат следующие ЛС:
| Наименование лекарственного препарата | Номер серии | Номер декларации о соответствии | Дата принятия декларации о соответствии |
| «Лизиноприл, таблетки 20 мг 30 шт., упаковки контурные ячейковые (1), пачки картонные» | 180819 | РОСС RU Д-Ки.РА01.В.43324/19 | 20.08.2019 |
| «Метопролол, таблетки 25 мг 30 шт., упаковки контурные ячейковые (2), пачки картонные» | 150819 | РОСС RU Д-RU.PA01.B.46478/19 | 16.09.2019 |
| «Метопролол, таблетки 50 мг 30 шт., упаковки контурные ячейковые (1), пачки картонные» | 220719 | РОСС RU Д-Ви.РА01.В.40956/19 | 31.07.2019 |
| «Метопролол, таблетки 50 мг 30 шт., упаковки контурные ячейковые (1), пачки картонные» | 240919 | РОСС RU Д-Ви.РА01.В.49109/19 | 02.10.2019 |
Причина для отзыва — отсутствие на первичной упаковке напечатанной фразы «годен до». Это является нарушением требований нормативной документации по параметру «Маркировка».
Росздравнадзор предлагает всем субъектам обращения лекарственных средств провести проверку наличия данных серий в ассортименте и предоставить в территориальный орган информацию, подтверждающую изъятие их из обращения.
Ранее из обращения был отозван метформин, у которого на вторичной и первичной упаковках были указаны разные дозировки.
«Катрен-Стиль» ежемесячно публикует обзоры информационных писем Росздравнадзора, посвященных отзыву и изъятию ЛС, а также последним изменениям в ГРЛС. Большое количество данных в таких статьях организовано в виде таблиц — по ним удобно проверять свой ассортимент на наличие «карантинных» или лишившихся регистрации препаратов. Последний обзор с перечнем таких ЛС смотрите в статье «Карантинная зона».
17 марта 2020
Фото: depositphotos.com
Выпуск: №194, март 20208006 просмотров
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