现在位置:首页 » GMP »强生召回泰诺林、美林等药物,FDA强烈建议暂时停止使用该药物

强生召回泰诺林、美林等药物,FDA强烈建议暂时停止使用该药物

时间:2010年05月05日 ⁄ 分类: GMP 评论:0

  泰诺林、美林口服液,还有仙特明滴剂等已经被FDA建议暂时停用。

  这几个药物在儿童中使用非常广泛。
Johnson & Johnson's recalls infant, children's Tylenol, Motrin

Sun May 2, 2010 1:37am EDT
(Reuters) - The Food and Drug Administration on Saturday urged consumers to stop using liquid Tylenol, Motrin, Benadryl and Zyrtec medicines for children and infants after a broad recall announced by the manufacturer, although it said the chance of serious problems was remote.

U.S. | HEALTH

Johnson & Johnson's consumer division announced a broad recall of products, including certain liquid infant's and children's Tylenol, Motrin, Zyrtec, and Benadryl products late on Friday.

A full list of the over 40 affected products made by McNeil Consumer Healthcare is available at [separator]www.mcneilproductrecall.com

"We want to be certain that consumers discontinue using these products," FDA Commissioner Margaret Hamburg said in a statement.

"While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more," she said.

McNeil said it was recalling the products in consultation with the FDA after discovering manufacturing deficiencies that could affect the quality, purity or potency of the medicines.

The FDA said some of the products may not meet required quality standards, and parents and caregivers should stop administering them to children and switch to generic brands, which are not affected by the recall.

They said consumers should not administer adult strength medicine to infants or children since that could result in serious harm.

Some of the products affected by the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles, the FDA said.

The FDA said the chance of an adverse reaction was remote, but urged consumers to contact their doctors and the FDA if their children exhibited any symptoms.

McNeil Consumer said it was recalling all lots of the over-the-counter products. The medicines were manufactured in the United States and distributed in the United States, Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago, and Kuwait.

It said consumers with questions about the recall could contact the company at 1-800-222-6036 or the website.

目前有 0 条评论

//ad_com//
//125*125//