包装瑕疵致数批口服避孕药Introvale被召回

圣路易斯(MD Consult)——2012年6月5日，美国食品药品管理局(FDA)宣布，由于近期接到1例包装瑕疵的报告，山德士公司正在主动召回10批(批号为LF00478C、LF00479C、LF00551C、LF00552C、LF00687C、LF00688C、LF00763C、LF00764C、LF00765C和LF01261C)的非专利口服避孕药Introvale。这种包装瑕疵导致严重不良健康后果的几率很低，山德士公司表示尚未接到任何相关不良事件的报告。

之所以发起这次召回，是因为1名消费者报告称，白色安慰剂药片被错误地装在了吸塑卡的第9排，而不是最后一排——第13排——这一正确位置。每板3个月吸塑卡含有84粒桃色的活性药片和7粒白色的安慰剂药片，列成13排，每排代表1周的用药。尽管白色安慰剂药片与桃色活性药片有明显区别，但不能排除消费者服用错误的药片而导致意外妊娠的风险。

与使用该产品有关的不良反应或质量问题，可报告至FDA的MedWatch不良事件报告系统。

爱思唯尔  版权所有

ST LOUIS (MD Consult) - On June 5, 2012, the US Food and Drug Administration (FDA) announced that Sandoz is conducting a voluntary recall of 10 lots (lot#s LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C, and LF01261C) of its generic oral contraceptive Introvale in light of a recent report of a packaging flaw. The probability of this packaging flaw causing serious adverse health consequences is remote and Sandoz is not aware of any reports of related adverse events.

The decision to initiate this recall was made after a consumer reported that the white placebo tablets were mistakenly in the 9th row (labeled Week 9) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled Week 13). Each three-month blister card contains 84 peach-colored active tablets and 7 white placebo tablets in 13 rows, each representing 1 week. Although the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program.