ST LOUIS (MD Consult) - On November 18, 2009, the US Food and Drug Administration (FDA) announced that RockHard Laboratories is conducting a voluntary nationwide recall of certain lot numbers of a dietary supplement sold under the name RockHard Weekend. The company decided to initiate the recall after being informed that an FDA laboratory analysis of the product revealed the presence of sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for erectile dysfunction (ED). RockHard Laboratories has identified that one of the outsourced laboratories it employs was using raw ingredients sourced from China that were unknowingly tainted with sulfoaildenfil.
The active drug ingredient is not listed on the product label, and the presence of sulfoaildenafil in the product qualifies it as an unapproved drug. This undeclared drug ingredient may interact with nitrates and cause significant hypotension. Consumers with diabetes, hypertension, elevated cholesterol levels, or heart disease often take nitrates, and because ED is a common problem in men with these conditions, they may seek out such products to enhance sexual performance.
The following products and lot numbers of RockHard Weekend are involved in this recall:
- single blister packs: T12 705 08 (exp 10/11) and T12 705 09 (exp 3/12, 8/12);
- 3-count bottles: R417 0509 (exp 09/12); and
- 8-count bottles: T237-0509 (exp: 06/12).
The FDA is advising consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional.
圣路易斯(MD Consult)—2009年11月18日，美国食品药品管理局(FDA)宣布，RockHard Laboratories公司正在全国范围内主动召回某些批号的商品名为“RockHard Weekend”的膳食补充剂。FDA实验室检出此产品中含有sulfoaildenafil[一种西地那非类似物， FDA批准用于治疗勃起功能障碍(ED)的药品]，RockHard Laboratories公司在接到此通知后决定发起召回。该公司现已查明，其聘用的一个外包实验室正使用一些源于中国且在未知情况下受到sulfoaildenfil污染的原材料。
此有效药物成分未在产品说明书中明示，而产品中含有sulfoaildenafil成分，故其为未批准的药品。这种未申报的药品成分可与硝酸盐发生相互作用，引起严重低血压。存在糖尿病、高血压、胆固醇水平升高或心脏病的患者常服用硝酸盐类药物，患有上述疾病的男性常存在ED，故其可能会使用此类产品以增强性功能。
此次召回中涉及下列RockHard Weekend产品和批号：
- 单泡罩包装：T12 705 08 (有效期：2011年10月) 和 T12 705 09 (有效期：2012年3月和2012年8月)；
- 3个/瓶：R417 0509 (有效期：2012年9月)；以及
- 8个/瓶：T237-0509 (有效期：2012年6月)。
对于因服用增强性功能的产品而发生过任何不良事件的消费者，FDA建议其咨询医护专业人员。
