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碳酸二羟铝钠咀嚼片(Rolaids)中含有金属颗粒和木质颗粒促使厂家将其召回
Metal and wood particles found in Rolaids Softchews prompts recall
ST LOUIS (MD Consult) - On December 9, 2010, McNeil Consumer Healthcare announced that it is voluntarily recalling all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed in the United States. McNeil is taking this action after receiving consumer reports of foreign materials in the product, including metal and wood particles.
McNeil has determined that the foreign materials were potentially introduced into the product during the manufacturing process at a third-party manufacturer. Investigation of the problem is ongoing, and McNeil has suspended production of the products in question and will not restart production until corrective actions have been implemented. The company believes the risk of serious adverse health consequences is remote, but is advising consumers who have purchased these recalled products to discontinue use.
Consumers with medical concerns or questions are being instructed to seek medical advice. Adverse reactions may be reported to the MedWatch Adverse Event Reporting Program of the US Food and Drug Administration.
The recalled products are listed in the table below:
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Product Name
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Lot Number
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UPC
|
|
Rolaids Extra Strength Softchews, Wild Cherry
|
|
Rolaids Extra Strength Softchews, Wild Cherry, 6-count
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9015A, 9016A,
9019A, 9140A,
9138A,9210A,
9211A,9315A,
9316A
|
312547655200
|
|
Rolaids Extra Strength Softchews, Wild Cherry, 18-count (3 packs of 6-count)
|
9075A, 9076A,
9103A, 9098A,
9104A, 9239A,
9240A, 9348A
|
312547655255
|
|
Rolaids Extra Strength Softchews, Wild Cherry, 42-count (7 packs of 6-count)
|
9065A, 9068A,
9069A, 9131A,
9132A, 9208A,
9209A, 9286A,
9287A
|
312547655316
|
|
Rolaids Extra Strength Softchews, Cherry
|
|
Rolaids Extra Strength Softchews, Cherry, 6-count
|
0109A, 0114A,
0115A, 0134A,
0135A, 0165A,
0238B, 0239A,
0239C, 0262A,
0264A
|
312547655200
|
|
Rolaids Extra Strength Softchews, Cherry, 18-count bag
|
0109A, 0114A,
0115A, 0134A,
0135A, 0165A,
0238B, 0239A,
0239C, 0262A,
0264A
|
312547655200
|
|
Rolaids Extra Strength Softchews, Cherry, 36-count bag
|
9350AG2, 0012AG1,
0013AG1, 0014AG1,
0015AG1, 0015AG4,
0050AG2, 0053AG2,
0053BG1, 0053BG2,
0094AG1, 0106AG1,
0106BG1, 0108AG2,
0108BG2, 0191AG1,
0139BG2, 0165BG1,
0191BG1, 0207AG1,
0207AG2, 0213AG1,
0227AG1, 0246AG2,
0247AG1, 0265AG1,
0266AG1
|
300450649362
|
|
Rolaids Extra Strength plus Gas Softchews, Tropical Fruit
|
|
Rolaids Extra Strength plus Gas Softchews, Tropical Fruit, 6-count
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9005A, 9006A
|
312547065733
|
|
Rolaids Extra Strength plus Gas Softchews, Tropical Fruit, 12-count (2 packs of 6-count)
|
9022A, 9027A,
9118A, 9119A,
9195A, 9196A
|
312547065757
|
|
Rolaids Extra Strength plus Gas Softchews, Tropical Fruit, 36-count (6 packs of 6-count)
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9166A, 9167A
|
312547065771
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Rolaids Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit
|
|
Rolaids Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 6-count
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0017B, 0095A,
0096B, 0259A,
0260A
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300450657060
|
|
Rolaids Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 12-count bag
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9351BG1, 9352AG1,
0016AG1, 0059AG2,
0059BG1, 0059BG2,
0060AG2, 0167AG2,
0167AG3, 0203AG1,
0204AG1
|
300450657121
|
|
Rolaids Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 24-count bag
|
9352AG2, 9352BG2,
0016AG2, 0017AG1,
0057BG1, 0058AG1,
0059AG1, 0059BG3,
0060AG1, 0129AG1,
0132AG1, 0167AG1,
0167BG1, 0204AG2,
0205AG1, 0230AG1,
0231AG1
|
300450657244
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圣路易斯(MD Consult)——2010年12月9日，麦克尼尔消费者医疗保健公司宣布，该公司正主动召回在美国销售的所有批次的Rolaids Extra Strength Softchews、Rolaids Extra Strength plus Gas Softchews和Rolaids Multi-Symptom plus Anti-Gas Softchews。麦克尼尔公司采取此次行动的起因是收到了关于本产品中含有金属颗粒和木质颗粒等异物的消费者报告。
麦克尼尔公司已经确定，这些异物可能是在第三方生产商生产过程中被引入到本产品中的。有关此问题的调查正在进行中，麦克尼尔公司已经暂时停止生产这些问题产品，而且在采取纠正措施之前不会再生产该产品。公司认为严重不良健康后果的发生风险极小，但仍建议购买这些被召回产品的消费者停止使用。
FDA建议有医疗安全隐患或问题的消费者向医生咨询，可将不良反应上报至美国食品药品管理局的MedWatch Adverse Event Reporting Program。
被召回产品如下表所列：
|
产品名
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批号
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通用产品代码(UPC)
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Rolaids Extra Strength Softchews，野樱桃味
|
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Rolaids Extra Strength Softchews，野樱桃味， 6片
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9015A, 9016A,
9019A, 9140A,
9138A,9210A,
9211A,9315A,
9316A
|
312547655200
|
|
Rolaids Extra Strength Softchews，野樱桃味，18片(6片/包，3包)
|
9075A, 9076A,
9103A, 9098A,
9104A, 9239A,
9240A, 9348A
|
312547655255
|
|
Rolaids Extra Strength Softchews，野樱桃味，42片(6片/包，7包)
|
9065A, 9068A,
9069A, 9131A,
9132A, 9208A,
9209A, 9286A,
9287A
|
312547655316
|
|
Rolaids Extra Strength Softchews，樱桃味
|
|
Rolaids Extra Strength Softchews，樱桃味， 6片
|
0109A, 0114A,
0115A, 0134A,
0135A, 0165A,
0238B, 0239A,
0239C, 0262A,
0264A
|
312547655200
|
|
Rolaids Extra Strength Softchews，樱桃味，18片/袋
|
0109A, 0114A,
0115A, 0134A,
0135A, 0165A,
0238B, 0239A,
0239C, 0262A,
0264A
|
312547655200
|
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Rolaids Extra Strength Softchews，樱桃味，36片/袋
|
9350AG2, 0012AG1,
0013AG1, 0014AG1,
0015AG1, 0015AG4,
0050AG2, 0053AG2,
0053BG1, 0053BG2,
0094AG1, 0106AG1,
0106BG1, 0108AG2,
0108BG2, 0191AG1,
0139BG2, 0165BG1,
0191BG1, 0207AG1,
0207AG2, 0213AG1,
0227AG1, 0246AG2,
0247AG1, 0265AG1,
0266AG1
|
300450649362
|
|
Rolaids Extra Strength plus Gas Softchews，热带水果味
|
|
Rolaids Extra Strength plus Gas Softchews，热带水果味，6片
|
9005A, 9006A
|
312547065733
|
|
Rolaids Extra Strength plus Gas Softchews，热带水果味，12片(6片/包，2包)
|
9022A, 9027A,
9118A, 9119A,
9195A, 9196A
|
312547065757
|
|
Rolaids Extra Strength plus Gas Softchews，热带水果味， 36片 (6片/包，6包)
|
9166A, 9167A
|
312547065771
|
|
Rolaids Multi-Symptom plus Anti-Gas Softchews，热带水果味
|
|
Rolaids Multi-Symptom plus Anti-Gas Softchews，热带水果味，6片
|
0017B, 0095A,
0096B, 0259A,
0260A
|
300450657060
|
|
Rolaids Multi-Symptom plus Anti-Gas Softchews，热带水果味，12片/袋
|
9351BG1, 9352AG1,
0016AG1, 0059AG2,
0059BG1, 0059BG2,
0060AG2, 0167AG2,
0167AG3, 0203AG1,
0204AG1
|
300450657121
|
|
Rolaids Multi-Symptom plus Anti-Gas Softchews，热带水果味，24片/袋
|
9352AG2, 9352BG2,
0016AG2, 0017AG1,
0057BG1, 0058AG1,
0059AG1, 0059BG3,
0060AG1, 0129AG1,
0132AG1, 0167AG1,
0167BG1, 0204AG2,
0205AG1, 0230AG1,
0231AG1
|
300450657244
|
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 疾病资源中心
王燕燕 王曙
上海交通大学附属瑞金医院内分泌科
患者，女，69岁。2009年1月无明显诱因下出现乏力，当时程度较轻，未予以重视。2009年3月患者乏力症状加重，尿色逐渐加深，大便习惯改变，颜色变淡。4月18日入我院感染科治疗，诉轻度头晕、心慌，体重减轻10kg。无肝区疼痛，无发热，无腹痛、腹泻、腹胀、里急后重，无恶性、呕吐等。入院半月前于外院就诊，查肝功能：ALT 601IU/L，AST 785IU/L，TBIL 97.7umol/L，白蛋白 41g/L，甲状腺功能：游离T3 30.6pmol/L，游离T4 51.9pmol/L，心电图示快速房颤。
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