關(guān)鍵詞: 雅培 AbbVie 藥物召回
2013年1月14日訊 /生物谷BIOON/ --上市不足3周,,AbbVie宣布首次藥物召回。AbbVie稱,,此次行動已召回超過28500瓶甲狀腺藥物Synthroid(合成甲狀腺素),,原因是在一個(gè)批次的一瓶Synthroid(150mcg片劑)中發(fā)現(xiàn)了低劑量(75mcg)片劑,AbbVie發(fā)言人Gregory Miley稱,,此次藥片混淆是由一條生產(chǎn)線的清理故障所致,。(生物谷bioon.com)
英文原文:Less than three weeks old, and AbbVie ($ABBV) has announced its first recall. The company said it recently pulled more than 28,500 bottles of the thyroid drug Synthroid because of a tablet mix-up. As The Wall Street Journal reports, it's the second Synthroid recall in 6 months.
The recall applies to one lot of 150-mcg tablets. Tablets of the lower 75-mcg dosage were found in one bottle in that lot. AbbVie spokesman Gregory Miley told the WSJ that the tablets were misplaced because of a clearance error on one manufacturing line.
The mix-up and resulting recall happened before AbbVie entered 2013 as a newly independent company, having been spun off from Abbott Laboratories ($ABT). It follows a July recall--involving three lots of the drug--that was caused by defective bottles that might have shortened the drug's shelf life. More than 136,500 bottles were involved, but most of them had not yet shipped, the company said.
Other drugmakers have been caught by line-clearance errors. Novartis ($NVS) had to pull drugs made at its Lincoln, NE, consumer health plant after some bottles were found to contain the wrong drugs and others contained broken tablets.