部分尼莫地平胶囊内出现结晶引发产品召回

圣路易斯(MD Consult)——2012年9月4日，美国食品药品管理局(FDA)宣布，Sun制药公司正在主动召回2批(批号为 3305.039A和3305.039B)泡罩包装的30 mg尼莫地平胶囊，这些药品是由Caraco制药实验室销售的。之所以发起本次召回，是因为Sun制药公司收到消费者投诉，称在胶囊溶液中发现了尼莫地平结晶。目前尚未收到相关不良事件的报告。

胶囊中的尼莫地平结晶可对产品的生物利用度产生负面影响。尼莫地平发生结晶的产品可能不再具有生物等效性，可能对正在接受紧急治疗的患者产生影响。尼莫地平被用于治疗蛛网膜下腔出血。

与使用应召回产品有关的不良反应，可报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On September 4, 2012, the US Food and Drug Administration (FDA) announced that Sun Pharmaceuticals is conducting a voluntary recall of 2 lots (lot#s 3305.039A and 3305.039B) of 30-mg nimodipine capsules that are packaged in unit-dose blister packs and are marketed by Caraco Pharmaceutical Laboratories. The recall was initiated after the company received a complaint that a customer had observed crystals of nimodipine within the capsule solution. No adverse events have been reported at this time.

The crystallization of the nimodipine fill material in the capsule could adversely affect the product's bioavailability. Although clinical health implications are unknown, use of the product when the nimodipine has crystallized in the capsule may be of great clinical significance. The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency. Nimodipine is used in the treatment of subarachnoid hemorrhage.

Adverse reactions experienced with the use of the recalled products may be reported to the FDA's MedWatch Adverse Event Reporting Program.

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