"개선 완료" 동아제약 '챔프시럽'·대원제약 '콜대원키즈펜시럽' 판매 재개

식품의약품안전처[촬영 이승민](서울=연합뉴스) 김현수 기자 = 식품의약품안전처는 갈변현상과 미생물 한도 부적합이 확인된 동아제약의 '챔프시럽'과 상분리 현상이 발생한 대원제약의 '콜대원키즈펜시럽'에 대한 제조·판매 중지 조치를 해제했다고 10일 밝혔다. 식약처는 해당 업체들이 제품 회수를 통해 문제의 원인을 분석하고 제제 개선 조치를 실시해 제출한 자료의 내용이 타당한 것으로 판단해 이같이 결정했다고 전했다. 이에 따라 챔프시럽과 콜대원키즈펜시럽은 즉시 공장에서 출고를 시작하고 약국으로 유통될 예정이다. 앞서 동아제약의 챔프시럽 일부 제품에서 갈변현상과 대원제약의 콜대원키즈펜시럽에서 가루와 액체가 분리되는 상분리 현상이 나타난다는 주장이 제기됨에 따라 식약처가 제조·판매를 중지한 바 있다. 식약처에 따르면 동아제약은 챔프시럽의 갈변현상이 제품에 함유된 감미제가 갈변 반응을 일으켜 발생했으며, 제품 자체의 낮은 보존력으로 인해 감미제에서 기인한 진균이 증식해 미생물이 기준을 초과한 것으로 파악했다. 이에 동아제약은 갈변반응과 진균 초과 검출의 원인이 된 감미제의 사용을 중단하고 제품에 보존제를 추가했으며 제조 공정 중 미생물 사멸을 위한 열처리 공정을 추가했다고 식약처는 전했다. 식약처는 동아제약에 행정처분 사전 통지를 했으며, 이후 행정처분을 진행할 예정이라고 설명했다. 또한 식약처는 콜대원키즈펜시럽의 경우 낮은 점도와 밀도로 인해 주성분이 침강하면서 맑은 투명 액상과 흰색의 불투명 액상으로 분리되는 현상이 발생한 것으로 대원제약이 분석했다고 전했다. 이에 대원제약은 첨가제 분량 등을 변경해 상이 분리되지 않고 안정적으로 유지됨을 입증했다고 식약처는 덧붙였다. hyunsu@yna.co.kr.
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