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Product Recalls Include Drugs, Peanuts, Egg Salad

Recall-SidebarThe Food and Drug Administration issued recall alerts for three items today: dietary supplements with unapproved drugs; peanut butter bars with mislabled wrappers and egg salad sandwiches available at convenience markets, airports, etc.

DIETARY SUPPLEMENTS

Healthy People Co. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers:

Product Name

Packaging

Lots

Mince Belle Dietary Supplement

30 Capsules

HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021; UPC7503013203305

PERFECT Men Dietary Supplement

30 Capsules

HPCPM/002; UPC7503013203190

EVERLAX Dietary Supplement

30 Capsules

HPCEX/074, HPCEX/076, HPCEX/072; UPC7503013203046

EVER Slim Dietary Supplement

30 Capsules

HPCES-079, HPCES-070, HPCES-071; UPC7503013203053

Herbal Drink Acai-man Mangosteen Dietary Supplement

16.6 fl oz

HPJAC/004 : UPC7503013203015

EVER SLIM Shake Mix Dietary Supplement Strawberry

17.6 oz

HPESSF/168: UPC7503013203084

EVER SLIM Shake Mix Dietary Supplement Chocolate

17.6 oz

HPESSC/061: UPC7503013203077

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.


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Sibutramine is an FDA-approved drug for appetite suppressant for the treatment of obesity, making dietary supplements: Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Strawberry, and Ever Slim Shake Mix Dietary Supplement Chocolate unapproved drugs. It is a Schedule IV controlled substance and because of the risks associated with its use, it should be taken only under the direct supervision of a qualified health care professional.

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine has been withdrawn from the U.S. marketplace. The active drug ingredient is not listed on the label for the products listed above.

Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Perfect Men Dietary Supplement and Herbal Drink Acai-man Mangosteen Dietary Supplement unapproved drugs.

FDA advises that this poses a threat to consumers because tadalafil 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. Healthy People Co. advises any customers in possession of the products listed above with matching the lot numbers to return any unused product for a full refund to the company directly. Customers can call 626-939-4132 M-F 9am-5pm (PST) for instructions on the return and refund process.

These products were sold, or distributed at our store located at: 13105 Ramona Blvd Ste F, Irwindale, CA, 91706, and can be returned, and exchanged at the same location.

Healthy People Co. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. Healthy People Co. promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: http://www.fda.gov/MedWatch/report.htm9

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

UNDECLARED PEANUTS IN PEANUT BUTTER SANDWICHES

Nest Collective ™ announced today that it is voluntarily recalling 8150 selling units of its Jammy Sammy™ - Strawberry Jam & Peanut Butter Flavor Snack Size Sandwich Bars due to a mislabeled inner wrapper. The cartons contain the best by date June 28, 2012 and are marked with the following universal product code (UPC) #89676600116 6 located on the bottom of the package. People who have an allergy or severe sensitivity to peanuts (or peanut butter) run the risk of serious or life-threatening allergic reaction if they consume these individual bars.

These cartons are sold online and at retail stores nationwide.

No illnesses have been reported in connection with this product and no other Revolution Foods products are affected.

The recall was undertaken because, while the cartons of this lot of product are correctly labeled, some of the individual bars are incorrectly labeled as Grammy Sammy - Honey Graham and Strawberry Yogurt™, and show the ingredient statement of that product. Both the selling unit and individually wrapped bars include information that the product was produced in a facility that processes peanuts as well as other allergens. The Jammy Sammy™ product contains organic peanut flour and organic peanut extract, but the inner wrappers are mislabeled with the Grammy Sammy information. Consumers who are allergic to peanut products should not use these products. People experiencing any health issue should seek immediate medical attention.

Specific UPC codes for these products are below:

Brand

Product

Flavor

Package

Best By

UPC

Revolution Foods

Jammy Sammy

Strawberry Jam & Peanut Butter

5 count carton

06/28/12

8 96766 00116 6

 

 

 

Images of the 5 count carton can be found at http://products.revfoods.com/products/jammy-sammy.

Consumers who purchased this product should return it to the store where it was purchased for a full refund or contact Nest Collective at info@nest-collective.com.

The recall is being undertaken with the knowledge of the U.S. Food & Drug Administration. Consumers with any questions are asked to call 1-866-362-1562 between the hours of 8am – 8pm EST Monday – Friday and 8am – 5pm EST Saturday & Sunday, or email: info@nest-collective.com.

“The Jammy Sammy™ product meets Nest Collective’s high standard for quality, however due to a labeling error during production, we are proactively removing this product from the market” said Neil Grimmer, Founder & CEO of Nest Collective.

“As a father, the safety and satisfaction of our consumers and their children is my highest concern,” said Neil Grimmer. “Nest Collective was founded on the vision of superior quality and nutritious food; we are committed to these values and our consumers.”

EGG SALAD SANDWICHES/CONVENIENCE-VENDING

GH Foods CA, LLC was notified by their supplier that the eggs supplied to them were from Michael Foods, Inc, who recalled Hard-Cooked eggs due to potential contamination by Listeria monocytogenes.

GH Foods CA, LLC, Sacramento, California, is therefore recalling sandwiches, associated with the affected eggs, due to potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and individuals with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and still births among pregnant women.

The sandwiches affected by the recalled eggs from Michael Foods, Inc., were distributed in the state of California. Products were sold in Walgreens retail stores only.

The product is packaged in a cellophane wrapper and sold under the Delish brand. Products affected include the code dates listed below. Code dates are listed on the Principal Display Panel.

Product

 

UPC Code

Enjoy by Date

DeLish brand Egg Salad on HoneyWheat Sandwich

8.5 oz.

0.49022-51925.1

1/17/12 through 2/5/12

DeLish brand Tuna Salad on Multigrain Bread Sandwich

8.5 oz

0.49022-51928.2

1/22/12 through 2/5/12

 

There have been no confirmed reports of illness associated with these products.

Consumers who may have the product, including expired product, are urged to discard the product or return it to the store for a refund.

If consumers have additional questions or concerns regarding these sandwiches, please contact Donald Johnson at (888) 449-9386, Monday-Friday 8 am – 5 pm, PST.