FDA Alert: Blue Square Market Issues Update to Voluntary Nationwide Recall of Kaboom Action Strips and Lida Daidaihua Due to the Presence of Undeclared Sulfoaildenafil, Sibutramine and Phenolphthalein
This is a reprint of an FDA Alert.
Recall — Firm Press Release
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Consumer: 1-877-919-9992
FOR IMMEDIATE RELEASE – August 17, 2015 (UPDATE to August 6, 2015 Original Press Release) – North Huntingdon, PA – Blue Square Market Inc. of North Huntingdon, PA, is issuing this updated recall notice to the previous Press Release dated 8/6/15 in order to correct and clarify manufacturer/distributor information and product codes. Original notice appears below with necessary revisions:
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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of heart attacks and strokes.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 were marketed for men’s vitality and LiDa DaiDaiHua were marketed for weightloss. Kaboom Actions Strips were distributed by Nutrology USA, LLC. in packages of 12 strips in a black box with a picture of the strip on the front and the code 09/17 printed in black on a white sticker affixed to the side of the carton. LiDa DaiDaiHua, manufactured by Kunming Dali Industry & Trade Co., Ltd,. comes in a light green and grey box with a picture of a woman on the front, with a stamped “best before 20170103” 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 or Lida DaiDaiHua from Feb 23, 2015 to May 7, 2015 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.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.