Several Recalls Issued For Consumer Safety
Several product recalls were issued in the last few days by the U.S. Food and Drug Administration. Consumers are cautioned about Magic Power Coffee because it contains an undeclared controlled substance; Pure Base Garlic spread has been recalled because of undeclared milk and wheat products that could affect people with allergies; Kellogg’s has voluntarily recalled lots of their cereals Apple Jack, Corn Pops, Honey Smacks and Fruit Loops for an uncharacteristic smell coming from box liners and Proctor and Gamble is recalling its Sinex VapoSpray because of anticipated expiration problems. The details on each recall are listed below:
Magic Power Coffee
INZ Distributors/Magic Power Coffee Inc. of Brooklyn, NY announced today that it is conducting a voluntary nationwide recall of the dietary supplement product sold under the name, Magic Power Coffee.
The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of one lot of the product by the FDA found that the product contains undeclared hydroxythiohomosildenafil, similar in structure to Sildenafil, an FDA-approved drug used for the treatment of male Erectile Dysfunction (ED), making Magic Power Coffee an unapproved drug. The hydroxythiohomosildenafil drug ingredient is not listed on the product label.
Hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Magic Power Coffee is distributed nationwide on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing program. It is sold in a 2-serving box with UPC 718122686872 and a 12-serving carton containing six 2-serving boxes with UPC 718122686773. All production dates up until 05/08/2010 are being recalled.
To date, no illnesses have been reported to the company or the FDA in connection with this product.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Consumers and health care professionals should report adverse events that may be related to the use of this product to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm1, by phone at 1-800-FDA-1088 or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm2 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.
Consumers should return any unused product to the place of purchase for full refund or contact INZ Distributors Inc./Magic Power Coffee Inc. at (718) 313-1579, Monday – Friday, 10 am to 6 pm EDT, for further instructions.
Pure Base Garlic Spread Concentrate
Pure Base Distribution, LLC of Ontario, CA is recalling its 4 ounce bottles of “Pure Base Garlic Spread - Concentrate” and 7 ounce bottles of “Pure Base Garlic Spread - Ready to Spread” items because they may contain undeclared milk and wheat. People who have allergies to milk and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. If you or a member of your household is allergic to milk or wheat products, do not consume these products, but return them to your retailer for a full refund.
"Pure Base Garlic Spread - Concentrate" and "Pure Base Garlic Spread – Ready to Spread" were distributed nationwide in online and traditional retail stores.
The "Pure Base Garlic Spread - Concentrate" product comes in 4 ounce clear plastic bottles and "Pure Base Garlic Spread - Ready to Spread" comes in 7 ounce clear plastic bottles. Both items have lot numbers and Best By Date stamped at the top of their red cap. Affected Lot Numbers with their Best By Dates are as follows:
Pure Base Garlic Spread Concentrate:
92221, Best By 8/10/2010
92391, Best By 8/27/2010
92661, Best By 9/23/2010
92921, Best By 10/19/2010
93291, Best By 11/25/2010
100341, Best By 2/3/2011
100971, Best By 4/7/2011
101181, Best By 4/28/2011
Pure Base Garlic Spread Ready to Spread:
92641, Best By 9/21/2010
93021, Best By 10/29/2010
93291, Best By 11/25/2010
100391, Best By 2/8/2011
101181, Best By 4/28/2011
No illnesses have been reported to date in connection with this problem. Anyone concerned about an allergic reaction should contact a physician.
The recall was initiated after it was discovered that the milk- and wheat-containing products were distributed in packaging that did not reveal the presence of milk and wheat on the label. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.
Distribution of the products has been suspended until the FDA and the company are certain that the products are properly labeled.
Consumers who have purchased 4 ounce bottles of "Pure Base Garlic Spread - Concentrate" and 7 ounce bottles of "Pure Base Garlic Spread - Ready to Spread" items are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-888-980-7474, ext 105, Monday through Friday 9 AM – 4 PM Pacific Standard Time.
Working in consultation with the United States Food and Drug Administration (FDA), Kellogg Company (NYSE:K) is implementing a voluntary recall of certain breakfast cereals due to an uncharacteristic off-flavor and smell coming from the liner in the package.
Only products with the letters "KN" following the Better If Used Before Date are included in the recall. Products with a "KM" designation are NOT included in the recall. In addition, no products in Canada are affected.
Kellogg's® Apple Jacks®
• UPC 3800039136 1: 17 ounce package with Better if Used Before Dates between APR 10 2011 and JUN 22 2011
• UPC 3800039132 3: 8.7 ounce packages with Better if Used Before Dates between JUN 03 2011 and JUN 22 2011
Kellogg's® Corn Pops®
• UPC 3800039109 5: 12.5 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
• UPC 3800039111 8: 17.2 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
• UPC 3800039116 3: 9.2 ounce packages with Better if Used Before Dates between APR 05 2011 and JUN 22 2011
Kellogg's® Froot Loops®
• UPC 3800039118 7: 12.2 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
• UPC 3800039120 0: 17 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
• UPC 3800039125 5: 8.7 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
Kellogg's® Honey Smacks®
• UPC 3800039103 3: 15.3 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
While the potential for serious health problems is low, some consumers are sensitive to the uncharacteristic off-flavor and smell and should not eat the recalled products because of possible temporary symptoms, including nausea and diarrhea.
No other Kellogg's products are part of this recall. The recalled products were distributed nationwide.
"We apologize to our consumers and our customers and are working diligently to ensure that the affected products are rapidly removed from the marketplace," said David Mackay, president and chief executive officer, Kellogg Company.
Those with questions or who would like a replacement may contact the Kellogg Consumer Response Center at 888-801-4163 from 8 am to 8 pm Eastern time.
The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling its 4-Hour Decongestant Nasal Spray. The product was distributed nationwide in the United States.
The company said it is taking this voluntary precautionary step after finding that the product formulation may not meet the expiration dates on the package. This recall is not a result of consumer complaints.
P&G is removing the product in question from store shelves. Consumers who have product with the UPC codes listed below and marked with an expiration date prior to June 2013 should simply discard the affected product. For further information on the product being recalled or to request a replacement coupon or refund call P&G toll-free at 877-340-8853 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday, 10AM – 3PM US ET).
The product name is: VapoSpray 4 Hour Nasal Spray by Sinex with a UPC code of 3 23900 00082 7. Prior to June 2009, this product was also sold as Sinex Nasal Spray in both a spray (UPC Code 3 23900 00082 7) and Ultra Fine Mist package (UPC Code 3 23900 00085 8).
Anyone experiencing an adverse reaction or quality problem with this or any medication should consult a health care professional and notify the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.