By: Heather Williams

Each week UnsafeFoods delivers updated information on recalls that may affect products you use every day.  This week’s Recall RoundUp brings you a Health Advisory on coffee, undeclared allergens in chocolate candy, and unapproved drugs.

Health Advisory

A Health Advisory is a notice that a product may contain something harmful.  These advisories result in a recall of the product and a notice to consumers to return or throw away the product.

Death Wish Coffee Co.:  Death Wish Nitro Cold Brew Cans Recall

On September 19, 2017, the Death Wish Coffee Co. or “Death Wish” of Round Lake New York has initiated a recall for the 11 oz Death Wish Nitro Cold Brew cans.  Death Wish is known for producing the “World’s Strongest Coffee”.

In conjunction with an outside Process Authority, Death Wish has determined that their current processing method could led to growth and production of the deadly toxin, botulinum, which is known to grown in low acid foods commercialized in reduced oxygen packaging.

Botulism, a potentially fatal form of food poisoning originating from consuming the toxin botulinum can present symptoms including dizziness, double-vision, trouble speaking or swallowing, and general weakness.  Other common symptoms include difficulty breathing, muscle weakness, constipation, and abdominal distention.  Those experiencing these symptoms should immediately seek medical attention.

“Our customers’ safety is of paramount importance and Death Wish Coffee is taking this significant, proactive step to ensure that the highest quality, safest, and of course, strongest Coffee products we produce are of industry-exceeding standards – thus we are taking this measure of recalling all Death Wish Nitro cans from shelves,” founder/owner of Death Wish Coffee Co., Mike Brown says. “We have also gone a step further, to make sure that everyone who purchased the product on deathwishcoffee.com will receive a full refund within 60 days. We apologize for the inconvenience this may cause our customers and our retail partners, but we believe this is the right precautionary measure to take.”

While Death Wish is working on modifying the manufacturing process for this canned beverage, production of Nitro Cold Brew has halted.  Death Wish Nitro cans are no longer available from the company’s online store and has been removed from shelves at Price Chopper/Market 32, Healthy Living Market & Café, and independent retailers at the request of Death Wish Coffee.

At this time no illness has been reported.  Those who have purchased Death Wish Nitro should not consume the product and should dispose of the product or return it to the location of purchase for a full refund.

Additional company information can be found online at DeathWishCoffee.com/Recall, on Facebook (fb.com/DeathWishCoffee), on Twitter (@DeathWishCoffee), and on Instagram (@DeathWishCoffee).

For press inquiries please contact [email protected]

For all other inquires please contact [email protected] or call toll free 1-844-303-2290 Monday through Friday from 8am-5pm EST.

Undeclared Allergen

An undeclared allergen recall occurs when a product containing a potential allergen does not have the item listed on the package or an allergen alert indicated.  Someone with a severe allergy or sensitivity could be exposed to severe or life-threatening reactions.

First Source: Tasty Treats Nonpareils Recall

On September 20, 2017 First Source of Pico Rivera, California has issued a recall for the Tasty Treat Nonpareils Milk Chocolate due to undeclared milk allergen.  Those with an allergy severe sensitivity to milk could have a serious or life-threatening allergic reaction.  The product was distributed in the state of California through Bristol Farms retail stores.

The recalled product can be identified as sold in a 5oz size plastic pouch containing round chocolate discs with colorful sprinkles, commonly known as nonpareils with a green paper label at top that states Tasty Treats, Nonpareils Milk Chocolate Bristol Farms with UPC 7 97299 00476 4 distributed between 12/20/2016 and 9/20/2017.

One incident has been reported to date.

The recall was initiated after discovering the product containing milk was distributed in packing labeled with the incorrect ingredient statement, which did not indicate the presence of milk.  Investigation revealed that the issue occurred during a temporary breakdown in the company’s label review process.

Consumers who have purchased this item are urged to destroy the product.  Consumers with questions may contact First Source at 1-716-389-0264, Monday – Friday, 8am – 5pm, EST.

Unapproved Drug

Drugs, including dietary supplements containing particular ingredients must be approved by the U.S. Food and Drug Administration (FDA).  Those containing potentially harmful components or unapproved by the FDA or subject to recall.

 Gadget Island Inc.: Dietary Supplement Recall

On September 20, 2017 Gadget Island, Inc. dba Gear Isle issued voluntary nationwide recall of select dietary supplements due to undeclared active pharmaceutical ingredients.

Rhino 7 Platinum 5000 capsules, LOT# R7-D5K1011H, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level.

The FDA analyzed the product and found these supplements to contain Sildenafil and Tadalafil.  These are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED), as well as Desmethyl Carbodenafil which is structurally similar to sildenafil. The presence of Sildenafil, Tadalafil and or Desmethyl Carbodenafil in Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000, and Grande X 5800, renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered tainted and FDA has received adverse event reports from consumers who have purchased these products.

To date, Gadget Island, Inc. dba Gear Isle has not received any reports of adverse events related to this recall.

These dietary supplements are marketed as male sexual enhancement.  The products were distributed Nationwide via internet sales.

Product Package Size UPC Lot# and EXP. date
Rhino 7 Platinum 5000 1 capsule in blister pack 6 17135 86122 4 R7-D5K1011H EXP:12/2017
Papa Zen 3300 1 capsule in blister pack 7 18122 03258 7 NSS050888 EXP: May 2018
Fifty Shades 6000 1 capsule in blister pack 4 026666 146056 All Lots
Grande X 5800 1 capsule in blister pack 6 40793 55544 0 All Lots

Gadget Island, Inc. dba Gear Isle is notifying its customers by email and is arranging for return and refunds of all recalled products. Consumers that have product (see table) which is being recalled should stop using and return to PO Box 1156 Newark CA 94560 for a refund.

Consumers with questions regarding this recall can contact Gear Isle customer service by calling 888-387-4753 or email at [email protected] on Monday to Friday from 10am to 4pm PST.  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 fax.

Natures Supplement, Inc.: Vegetable Vigra Recall

On September 20, 2017 Natures Supplement, Inc. issued a voluntary recall of 260 bottles of the supplement Vegetable Virgra, 200 mg capsules.  FDA analysis found this product to be tainted with Sidenafil.  Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy has not been established, therefore subject to recall.

Risk Statement: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that taken with these products could lower blood pressure to dangerous levels that could be life-threatening.

To date, Natures Supplement, Inc. has not received any reports of adverse events related to this recall.

The product, used as a natural male enhancement is packaged in a bottle with green label. The affected Vegetable Vigra includes all lots. It can be identified by label “enhanced Vegetable Vigra.”  The product was distributed in Florida to consumers through a third party distributor

Natures Supplement Inc is notifying its distributor by mail and working to arrange for the return of all recalled products. Distributors and consumers that have the recalled product should stop selling/using the product immediately and return to point of purchase.

Consumers with questions regarding this recall can contact Natures Supplement by phone 561-281-7212 Monday thru Friday 9am to 5pm Eastern Standard Time or [email protected]. 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

 

Sources:

https://www.fda.gov/Safety/Recalls/ucm576809.htm

https://www.fda.gov/Safety/Recalls/ucm576841.htm

https://www.fda.gov/Safety/Recalls/ucm576785.htm

https://www.fda.gov/Safety/Recalls/ucm576834.htm