ST LOUIS (MD Consult) - On December 8, 2009, the US Food and Drug Administration announced that Bayer is conducting a voluntary recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula (liquid gels). Bayer initiated the recall after identifying that the labeling on the foil blister card of certain packages within the lot (<4%) were printed with the label reversed. The label for the green Night product appears under some of the blue Day product and vice versa. As such, a risk exists that consumers may not be aware of the warnings that an antihistamine is in the product and could cause drowsiness.
All individual liquid-filled capsules are imprinted correctly.
The affected Alka-Seltzer Plus product lot number (296939L) can be found on both the interior blister package (in black text adjacent to the expiration date [5/11]) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo).
Consumers who purchased the product from the lot included in this recall are being instructed to stop using it and contact Bayer with any questions and/or instructions on obtaining a refund or replacement.
圣路易斯(MD Consult)——2009年12月8日,美国食品药品管理局宣布,拜耳公司正在主动召回单个批次的复方生物碱-塞尔策 “白加黑”抗感冒药(Alka-Seltzer Plus Day & Night Cold Formula)(液态凝胶剂)。拜耳公司在发现某单个批次中的部分包装(<4%)箔泡罩板上的标签印反了之后,立即着手召回该批次产品。夜间服用的绿色胶囊的标签被错误地移至日间服用的部分蓝色胶囊下,反之亦然。因此,消费者可能会忽视针对夜间服用胶囊的警示语,即产品中含有抗组胺成分,可能引起困倦。
所有单个充液胶囊上的标记是正确的。
所召回的复方生物碱-塞尔策产品批号为296939L,里面的泡罩包装[失效日期(5/11)旁边的黑色字体]和装有泡罩板的纸盒外包装上均印有产品批号(拜耳商标下方侧面的凸出文字)。
现召告购买了该批次产品的消费者立即停止使用该药,如有任何疑问或有关退款或更换产品的问题,请与拜耳公司联络。