(편집자 주 - 면역 체계 질환치료에 사용되는 옥타파마 (Octapharma) 미국법인의 정맥용 면역 글로불린(IGIV) 제품인 옥타감 (Octagam)5%의 제조사의 자발적 시판 철회 - Voluntary Market Withdrawal - 결정에 대한 내용입니다.)

URGENT: Voluntary Market Withdrawal - September 23, 2010 Octagam (옥타감) [Immune Globulin Intravenous (Human)] 5% Liquid Preparation

DATE MARKET WITHDRAWAL INITIATED:
September 23, 2010

PRODUCT:
Octagam (옥타감) [Immune Globulin Intravenous (human)] 5% Liquid Preparation

MANUFACTURER:
Octapharma (옥타파마) USA, Inc.
Hoboken, NJ

REASON:
On August 20, 2010, in the interest of patient safety, Octapharma (옥타파마) USA Inc. initiated a voluntary market withdrawal of selected lots of Octagam (옥타감) [Immune Globulin Intravenous (human)] 5% Liquid Preparation].

This was performed as a result of an increased number of reported thromboembolic events, some of which were serious. A total of 31 lots were voluntarily withdrawn at that time.

Effective immediately, Octapharma (옥타파마) USA Inc. is initiating a voluntary market withdrawal of ALL lots of Octagam (옥타감) [Immune Globulin Intravenous (human)] 5% Liquid Preparation] currently in the US market.

While Octapharma has not received any reports of thromboembolic events since the August 20, 2010, voluntary market withdrawal was performed, Octapharma has determined, through consultation with the public health authorities at FDA, that until a root cause of the previously reported thromboembolic events can be determined and the problem corrected, the most prudent course of action is to suspend further administration of Octagam (옥타감).

Customers are asked to immediately quarantine the use of these lots and to contact Octapharma’s Customer Service Department to arrange for product return.