Subject: Food and Drug Recalls
Date: 7/23/2010; 16:06:00
Message#: 101666-7-23-2010-PHIN
Contact Info: Alan L. Talarsky, NJDHSS/CEHS/Food and Drug Safety Program
Phone: 609-588-3123; Email:
at2@njlincs.netAttachments: None
Please review the following message from Alan Talarsky, Environmental Scientist 1, Food and Drug Safety Program, DHSS regarding the following Class 1 Recalls issued by the U.S. Food and Drug Administration:
1. DeBoles Nutritional Foods, Inc. announced that it is recalling one lot code of DeBoles® Kids Only! Gluten Free Tubettini Corn Pasta because it may contain undeclared whole wheat alphabet pasta. People who are allergic to wheat run the risk of an allergic reaction, which may be serious or life-threatening if they consume the recalled product.
The recalled lot was distributed to stores nationwide and through internet orders.
The product comes in a cardboard box, 8.5 ounce, with a clear plastic window. The expiration lot code is on the top of the box and the UPC Code 087336638305 appears on the bottom of the box. No other lot codes are affected. This recall only affects:
Deboles kids only! gluten free tubettini corn pasta
Lot code: 30JUN11D1
No illnesses have been reported in connection with this product. It appears that certain product boxes in lot code 30JUN11D1 may contain whole wheat alphabet pasta mixed with the gluten-free tubettini corn pasta in packaging that did not declare wheat as an allergen and, as a result, the product is being recalled. The alphabet pasta is clearly visible and is a darker color and characteristic alphabet shape compared to the yellow corn small-tube pasta.
Consumers who have purchased 8.5 ounce packages of DeBoles® Kids Only Gluten Free Tubettini Corn Pasta with Lot Number 30JUN11D1 are urged to return such packages to their place of purchase for a full refund. Consumers with questions may contact the company at 1-800-434-4246 during extended hours from Monday to Friday 9 am to 9 pm EDT, and on Saturday and Sunday from 10 am to 6 pm.
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2. J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Joyful Slim Herb Supplement distributed by the company was found to contain undeclared Desmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown.
FDA advises that this product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Joyful Slim Herb Supplement is marketed as a Natural Herb for Weight Loss. Joyful Slim Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 97966 00200 7. The affected lot/code being recalled is 101408. The product was sold to distributors and retail stores nationwide and via internet sales.
No illnesses or injuries have been reported to the company to date in connection with this product.
J & H Besta Corp. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of Joyful Slim. It sincerely regrets any inconvenience to our customers.
Consumers should not consume the Joyful Slim Herb Supplement and should return it immediately to the place of purchase for a full refund. Consumers with questions should contact Jason Wang at 877-547-5468, Monday through Friday, 10:00 am to 5:30 pm, EDT.
Any adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088 [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page], by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
No action is required of local health departments at this time for either of these recalls. If any requests for assistance are received from FDA, the Food and Drug Safety Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below.
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For all recalls - http://www.recalls.gov/recent.html
This information has been distributed to: DHSS Senior Staff; DHSS Staff; LINCS Coordinator Backups; LINCS Coordinators; LINCS Epidemiologists; LINCS Health Educators; LINCS Health Officer Assistants; LINCS Health Officers; LINCS Health Planners; LINCS IT Specialists; LINCS Partnership Coordinators; LINCS Public Health Nurses; LINCS Regional Health Planners; LINCS Team Members; LOCAL Health Officers; LOCAL Public Health; Food Safety Organizations
Further distribution of this message should be directed to: n/a
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