Safety Notices
ST LOUIS (MD Consult) - On September 18, 2009, McNeil Consumer Healthcare (in consultation with the US Food and Drug Administration) issued a notice to health care professionals that it is voluntarily recalling certain lots of children's and infants' Tylenol products that were manufactured between April 2008 and June 2008. The company has implemented this recall because examination of bulk raw material detected that one of the inactive ingredients used in certain medicinal products did not meet internal testing requirements. Specifically, gram-negative bacteria Burkholderia cepaciawere detected during the examination.
The portion of raw material in which the bacteria were found was isolated and was not used in the production of any finished product. However, McNeil decided, as a precaution, to recall all products that used any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. McNeil emphasized that no bacteria have been detected in finished Tylenol products, and the finished products have met all specifications.
A review of the relevant, published scientific literature regarding B cepacia (conducted by McNeil) indicates that while ingestion of contaminated pharmaceutical products is not known to be a route of transmission for B cepacia, infection with these bacteria has been reported after the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequence of B cepacia infections could be potentially severe, especially in high-risk patients such as those with underlying pulmonary disease, cystic fibrosis, or compromised immune systems.
A McNeil assessment of postmarketing safety surveillance data did not identify any safety signals or batch-related safety concerns for infants' and children's Tylenol products over the time period in question, starting with the introduction of these batches in or around April 2008.
McNeil's notice contains the full list of the recalled Tylenol products.
圣路易斯（MD Consult）——经与美国食品药品监督管理局磋商后，麦克尼尔消费保健公司于2009年9月18日向医疗专业人员发布一项公告说，该公司自愿召回于2008年4～6月生产的某些批次的儿童和婴儿用对乙酰氨基酚制品。该公司实施这次召回是因为在对大宗原材料检测时发现用于某些医药制品的无活性成分未达到内部检测要求。具体来说，在这次检测中发现了革兰氏阴性洋葱伯克霍尔德菌(Burkholderia cepacia)。
发现上述细菌的部分原材料已被分离出来，并未应用于任何成品中。但由于原材料中发现了细菌，作为预防措施，麦克尼尔公司对乙酰氨基酚成品中未检测出细菌，并且符合所有技术规格。仍决定召回同期应用同批原材料生产的所有产品。麦克尼尔公司强调已生产的
对由麦克尼尔公司洋葱伯克霍尔德菌的科学文献的综述发现，虽然应用受污染的药物并非洋葱伯克霍尔德菌的传播途径，但有应用细菌污染的药物引起洋葱伯克霍尔德菌感染的报道，如漱口剂和喷鼻剂。洋葱伯克霍尔德菌感染的不良健康后果可以很严重，尤其在高危人群中，如肺病、囊性纤维化或免疫功能低下的患者。组织发表的有关
麦克尼尔公司的一项上市后安全性监测数据评估显示，自2008年4月左右该药物几批次上市之后，在征询问题时期内并未发现任何有关婴儿和儿童用对乙酰氨基酚制品的任何安全信号或批次相关的安全顾虑。
麦克尼尔公司的公告中包括所召回的对乙酰氨基酚制品的完整目录。
