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Sunday, August 9, 2015

Male Vitality and weight loss product recalled

Blue Square Market Inc. of North Huntingdon, PA, is recalling "Kaboom Actions Strip 12 Pack" and LiDa DaiDaiHua to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients. Kaboom was found to contain sulfoaildenafil and LiDa DaiDaiHua was found to contain sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of heart attacks and strokes. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Sulfoaildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) which could lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time, no illnesses or injuries have been reported to Blue Square Market Inc. in connection with these products.
Kaboom Actions Strips are marketed for men’s vitality and LiDa DaiDaiHua is marketed for weight loss. Kaboom Actions Strips was purchased from the manufacturer Nutrology USA, LLC. Kaboom Action Strips comes in packages of 12 strips in a black box with a picture of the strip on the front of the box and a stamped expiration date of 9/17 on the box. LiDa DaiDaiHua was purchased from the manufacturer Green Cross Store. LiDa DaiDaiHua comes in a light green and grey box with a picture of a woman on the front, with a stamped expiration date of 1/17 on the bottom.
Blue Square Market’s online store, www.calcompnutrition.com was one of many that sold these retail products. Blue Square Market is neither the manufacturer nor the distributor of the product, only a retailer. Blue Square Market has pulled all of Kaboom Actions Strip 12 Pack and Lida DaiDaiHua from its online store, calcompnutrition.com, and will no longer carry this product line.
Blue Square Market is notifying its customers by letter and is arranging for return and refund of all recalled products. Consumers who have purchased Kaboom Actions Strip 12 Pack from March 20, 2015 to July 7, 2015 with expiration date of 9/17 or Lida DaiDaiHua from Feb 23, 2015 to May 7, 2015 with expiration date of 1/17 should immediately discontinue use and return them to Blue Square Market, Inc. for a full refund.
Consumers with questions regarding this recall can contact Blue Square market by phone at 1-877-919-9992 Monday - Friday from 9am to 4:30pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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