ST LOUIS (MD Consult) - On December 9, 2010, Reese Pharmaceuticals announced that it is conducting a voluntary recall of certain over-the-counter (OTC) guaifenesin-containing products because of mislabeling. The current labels indicate that the products contain only guaifenesin, and they do not list other active ingredients, including acetaminophen, phenylephrine, and clorpheniramine. The recalled products are marketed for the relief of cold symptoms.

To date, no reports of adverse events related to use of the recalled products have been received.

Labels for these products do not warn consumers that the use of acetaminophen, especially in high doses, may cause liver damage. The likelihood of acute liver damage is higher among consumers with preexisting liver disease and in those who drink 3 or more alcoholic beverages per day. Persons who are also taking other cold/cough products that contain acetaminophen in addition to the mislabeled products are at even higher risk for overdose.

Consumers with hypertension or impaired vascular function in the extremities and those taking monamine-oxidase inhibitors for depression should not take phenylephrine. Furthermore, products that contain phenylephrine should be used with caution in patients with diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or prostatic enlargement.

Consumers with allergies to any of the ingredients, patients with narrow-angle glaucoma, and pregnant or nursing mothers should not use these products.

The recalled products are listed in the table below: 

 

产品名称	NDC#	Lot#
Refenesen Expectorant (guaifenesin 200-mg tablets) Refenesen祛痰剂 (愈创甘油醚，200-mg片剂)	10956-752-60;	091612 05/11 SS/SCT36 06/26/09
Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)	15127-129-60	091612 05/11 SS/SCT36 06/26/09
QC Medifin Expectorant (guaifenesin 200 mg)	63868-754-60	091612 05/11 SS/SCT36 06/26/09
Leader Cough Tabs Expectorant (guaifenesin 200 mg)	37205-466-72	091612 05/11 SS/SCT36 06/26/09

 

圣路易斯(MD Consult)——2010年12月9日，Reese制药公司宣布其含甘油醚的非处方药因标签错误而被召回。当前的标签表示该产品仅含甘油醚，而并未列明其他活性成分，包括对乙酰氨基酚、去氧肾上腺素和氯喘息定。召回的产品主要是用于缓解感冒症状。

迄今为止尚未收到使用这些召回产品相关的报告。

这些产品的标签并未警告消费者使用对乙酰氨基酚(特别是在高剂量下)可能会造成肝损伤。若消费者有肝病史或每日饮用3瓶以上酒精饮料，则造成急性肝损伤的几率将大大增加。此外，服用其他含对乙酰氨基酚感冒药的患者在过量服药的情况下肝风险将大大增加。 

患高血压病或四肢血管功能受损的患者，以及服用单胺氧化酶抑制剂用于治疗抑郁症的患者不应该服用去氧肾上腺素。此外，糖尿病、心脏病、眼压升高、甲状腺机能亢进或前列腺肥大的患者应慎服含去氧肾上腺素的产品。

对以下成分有过敏反应、窄角型青光眼、怀孕期或哺乳期妇女应避免使用这些药品。 

被召回产品如下表所示：

 

产品名称	NDC#	Lot#
Refenesen Expectorant (guaifenesin 200-mg tablets) Refenesen祛痰剂 (愈创甘油醚，200-mg片剂)	10956-752-60;	091612 05/11 SS/SCT36 06/26/09
Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)	15127-129-60	091612 05/11 SS/SCT36 06/26/09
QC Medifin Expectorant (guaifenesin 200 mg)	63868-754-60	091612 05/11 SS/SCT36 06/26/09
Leader Cough Tabs Expectorant (guaifenesin 200 mg)	37205-466-72	091612 05/11 SS/SCT36 06/26/09