Category: Uncategorized

For Immediate Release
July 17, 2018

Contact
Consumers
Teva’s Medical Information
druginfo@tevapharm.com
888-838-2872

Announcement
Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

To date, TEVA has not received any reports of adverse events related to this recall. (more…)

For Immediate Release
July 12, 2018

Contact
Consumers
Papa John’s Salads and Produce
480-653-8901

Announcement
Papa John’s Salads and Produce of Tolleson, AZ is voluntarily recalling 148 units of the Superfood Salads due to misbranding and undeclared peanuts. The product contains peanuts which are not declared on the product label as packages of peanuts were mistakenly included in the kits instead of cashews.

People who have sensitivity or allergies to peanuts may be at risk of serious or life threatening allergic reaction if they consume this product. To this date, there have been no reported adverse reactions to this product. (more…)

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients (API)The presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. These products were distributed from January 2013, to December 2017, though our website http://www.mynicnaxs.com. The undeclared drug ingredients found in these products may pose serious health risks because consumers with underlying medical issues may take them without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. API found in FDA samples include the following:

Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated Sibutramine poses an increased risk of heart attack and stroke.

Phenolphthalein is a known carcinogen (cancer causing agent) that was once an ingredient used in over-the-counter laxatives but is no longer approved for marketing in the United States.

Sildenafil is the active pharmaceutical ingredient in Viagra (PDE-5 inhibitor), a drug approved by FDA for the treatment of erectile dysfunction. PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Diclofenac is a non-steroidal anti-inflammatory drugs (NSAIDs) found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions. NSAIDs could lead to serious gastrointestinal (GI) adverse events such as bleeding, ulceration, and fatal perforation of the stomach and intestines. Patients who are already taking medication that could cause bleeding may increase their risk for bleeding significantly.

Products listed below are being voluntarily recalled due to undeclared active pharmaceutical ingredients. The products can be identified by referring to the table below:

Product Description API Found in FDA Lab Results
Platinum Maximum Strength Blue Pill Version;
30 capsules; 500mg each Sibutramine and Phenolphthalein

Platinum Maximum Strength Blue Pill Version;
30 capsules; 500mg each Sibutramine and Phenolphthalein

Slimming Plus Advanced Weight Loss; 30
capsules; 500mg each Sibutramine and Phenolphthalein

African Viagra – sexual performance
enhancement product; 4500mg x 2 Sildenafil

GINSENG – sexual performance enhancement
product; 300mg/tablet x 10 tablets Sildenafi

African Superman – sexual performance
enhancement product; 2900mg x 8 tablets per
blister pack Sildenafil

Old Chinese – sexual performance enhancement
product; 19800mg x 10 capsules Sildenafil

Lean Extreme Max; 30 capsules; 400mg each Sibutramine
X-treme Beauty Slim; 30 capsules; 350mg each Sibutramine

African Superman – Top-Class Permanence
Tablet; 2900mg x 8 tablets Sildenafil

Slim Evolution – 100% Natural Ingredients; 30
capsules; 350mg each Diclofenac

Meizitang Strong Version capsules packed in a
non-flexible clear bottle with a green screw-on
top Sibutramine

Magic Slim capsules packed in a non-flexible
white bottle with a white screw-on top Sibutramine

Slim Xtreme capsules packed in a non-flexible
white bottle with a white screw-on top Sibutramine

Meizi Evolution capsules were packed in a non-
flexible clear bottle with a blue screw-on top Sibutramine

SlimEasy Herbs capsules packed in blister
packaging and placed in a white box with black
labeling Sibutramine

Hokkaido – capsules packed in blister packaging
in pink box with black labeling Phenolphthalein

Super Fat Burning Bomb capsules in blister
packs, packaged in a red box with black labeling Sibutramine and Phenolphthalein

FRUTA Bio blister packs, packaged in a
yellow/green box with green labeling Sibutramine and Phenolphthalein

JIANFEIJINDAN Activity Girl – blister packs,
packaged in a white/pink box with pink labeling Sibutramine

Reduce Weight FRUTA PLANTA blister packs,
packaged in a yellow/green box with green
labeling Phenolphthalein

Fat Loss Slimming Beauty – 30 capsules in
blister packs packaged in yellow/black box -500
mg Sibutramine and Phenolphthalein

Fruta Planta -blister packs packaged in
yellow/green box with green labeling Sibutramine and Phenolphthalein

Botanical Slimming – 100% Natural Soft gel; 30 soft gels; 650mg each packaged in a green bag with yellow and white lettering

Slim Body – Dietary Supplement;100% Herbal Slimming Formula; 30 capsules; 6x5x300mg blister packs, packaged in blue and red box

MyNicNaxs LLC, is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. No reports of adverse events have been reported to date. (more…)

Name of product:
Vernier Circuit Board 2
Hazard:

There are two switches on the VCB2 that can get stuck between positions causing the switches to short out and overheat.  If the switches overheat, the metal case of the switch can become hot, posing a burn hazard.

Remedy:
Repair
Recall date:
June 6, 2018
Units:
About 4,200
Consumer Contact:

Vernier Software & Technology toll-free at 888-837-6437 from 7 a.m. to 5 p.m. PT Monday through Thursday, 7 a.m. to 3:00 p.m. PT Friday, email at info@vernier.com or online at http://www.vernier.com and click on Vernier Circuit Board 2 Safety Recall Information banner for more information.

Recall Details

Description:

This recall only involves the Vernier Circuit Board 2.  It is a green-colored circuit board that is 10 inches wide by 6.5 inches in height and is used to teach students about the fundamentals of electrical circuits. The Vernier name, logo, product name (Vernier Circuit Board 2) and order code (VCB2) are printed in the upper right corner of the product.  Recalled units were shipped between August 2015 through April 10, 2018 represented with the different revision mark codes of ‘VCB2 REV 1 PPRL 2015’ and ‘VCB2 REV 1A PPRL 2015’ printed below the pins 35, 30, and 31 on the lower section of the product.

Remedy:

Consumers should immediately stop using the recalled circuit boards and return them to the firm for a free repair. Instructions for returning the units are available on the firm’s website.  Vernier is contacting known customers directly.

Incidents/Injuries:

The firm has received 10 reports of circuit board switches overheating. No injuries have been reported. (more…)

Name of product:
Propane (LP) gas
Hazard:

The recalled propane gas does not contain sufficient levels of odorant to help alert consumers to a gas leak. Failure to detect leaking gas can present fire, explosion and thermal burn hazards.

Remedy:
Replace
Repair
Recall date:
June 5, 2018
Units:
About 1.7 million gallons
Consumer Contact:

Keyera Energy toll-free at 844-879-8419 from 9 a.m. to 5 p.m. CT, email propane@keyera.com or online at www.keyera.com and click on “Propane Safety Update” on the Corporate Responsibility page or www.keypropaneupdate.com for more information.

Recall Details

Description:

This recall involves under-odorized propane (LP) gas delivered to consumers for use in storage tanks or sold at retail locations in portable refillable cylinders (for use in recreational vehicles, barbeques, stoves and other appliances). The LP gas was also sold to businesses for commercial and industrial use.  Keyera Energy Inc. does not sell propane directly to any retailers or consumers, but supplies propane to distributors that sell directly to retailers and consumers.

Remedy:

Consumers should not attempt to test the propane themselves. Instead, consumers who have propane delivered to storage tanks should immediately contact the retailer, supplier or Keyera Energy to arrange for a free inspection. If the inspection confirms that the propane contains insufficient odorant, Keyera Energy will arrange for additional odorization or a replacement of the under-odorized propane. Consumers should have carbon monoxide alarms in homes or other buildings that utilize propane gas. If consumers do smell even a faint odor of gas or a gas leak, they should immediately leave the building and call 911 or call their gas supplier. Do not light a match, turn on a light or switch on anything electrical.

Incidents/Injuries:

None reported (more…)

For Immediate Release

May 22, 2018

Contact

Consumers

Dennis Zeedyk
 (219) 369‐1066

Announcement

Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product (“Product”) because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals.

Ethanol Extraction’s Product was sold through the company’s website ‐‐ ethanolextraction.com ‐‐ and delivered by direct shipment throughout the U.S. The Product was sold in various size plastic bottles, ranging from 8 oz to 1 gallon, as well as 2.5 gallon and 5 gallon containers, containing labels such as depicted below.

The Product was first sold in October 2016 and last sold on April 30, 2018. The Product’s intended use is as a solvent for extracting essential oils from plant material, and contains warnings including “HARMFUL IF SWALLOWED. MAY CAUSE DAMAGE TO ORGANS.” The Product is not for human or animal consumption.

Recall of the Product was sparked by news that a man in Massachusetts allegedly ingested the Product and later died as a result. There have been no other reports of any ingestion or injury since the Product was first marketed in October 2016. (more…)

For Immediate Release

April 18, 2018

Contact

Consumers

 1-800-936-7936

Announcement

NutriZone, LLC of Houston, Texas is expanding its recall of various kratom dietary supplements to additional lot numbers, which contain the same source material as the original recalled lots. The expanded recall is being conducted out of an abundance of caution.

The recall of dietary supplements is due to the potential for contamination with Salmonella. Salmonella, is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

The dietary supplements are labeled and packaged as follows:

Product Name Net Quantity (Capsules Per Container) Lot Number Packaging
Pain Out Maeng Da 36 Pouch All
Pain Out Thai 108 Bottle 10960-D
Pain Out Malay 324 Bottle 10958-I
Nirvanio Green Malay 25 Bottle 10958-C
Nirvanio Special Reserve Kratom Blend 50 Bottle 10796
Nirvanio Special Reserve 100 10795 Bottle
Nirvanio Maeng Da 100 10957-A Bottle
Nirvanio Maeng Da 50 10957-B Bottle
Nirvanio Maeng Da 25 10957-C Bottle
Cali Maeng Da 100 10957-D Bottle
Cali Maeng Da 200 10957-E Bottle
Cali Maeng Da 300 10957-F Bottle
Pain Out Maeng Da 108 and 324 10957-G Bottle
Pain Out Maeng Da 216 10957-H Bottle
Nirvanio Green Malay 100 10958-A Bottle
Nirvanio Green Malay 50 (labeled and unlabeled) 10958-B Bottle
Cali Green Malay 100 10958-D Bottle
Cali Green Malay 200 10958-E Bottle
Cali Green Malay 300 10958-F Bottle
Pain Out Green Malay 108 10958-G Bottle
Pain Out Green Malay 216 10958-H Bottle
Cali Thai 100 10960-A Bottle
Cali Thai 200 10960-B Bottle
Cali Thai 300 10960-C Bottle
Pain Out Thai 216 (labeled and unlabeled) 10960-E Bottle
Pain Out Thai 324 10960-F Bottle
Nirvanio Maeng Da 50 10889 Bottle
Nirvanio Green Malay 100 10890 Bottle
Nirvanio Bali 50 10891 Bottle

Attached are images of product labels to aide in identifying product associated with this recall. Lot numbers can be found on the packaging near the Nutrition Facts Panel.

The products were sold in Pennsylvania, Oklahoma, Washington, Missouri, Florida, Mississippi, California and Texas.

No illnesses have been reported to date in connection with this problem. (more…)

For Immediate Release

October 21, 2017

Contact

Consumers

Earthbound Farm LLC
1-800-690-3200

Media

Samantha Cabaluna
betheunvarnished@gmail.com
831-293-4279

Announcement

Out of an abundance of caution, Earthbound Farm LLC of San Juan Bautista, CA is voluntarily recalling 1,755 cases of the Earthbound Farm Organic Chopped Asian Style Salad Kit with an expiration date of October 24, 2017 and UPC of 32601 95134, because it was discovered that some of the bags contain the dressing/toppings packets for the Southwest Chopped Salad Kit rather than for the Chopped Asian Style Kit. The Southwest dressing contains egg and milk that are not declared as ingredients on the bag of the Asian Style Salad Kit. A consumer contacted us after noticing the dressing packet declared “contains egg and milk,” allergens that are not declared on the label of the Asian Style Salad Kit. The Southwest dressing packets say “Southwest” on them. While no reactions have been reported to date, people who have an allergy or severe sensitivity to MILK or EGG run the risk of a serious or life-threatening allergic reaction if they consume these products. (more…)

For Immediate Release

June 23, 2017

Contact

Consumers

 800-217-2007

Media

Jackie Anderson
  media@adm.com
 312-634-8484

Announcement

ADM Animal Nutrition™, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death.

There is one lot number involved in this recall: Lot # 2WS01717. The product was distributed between Jan. 19, 2017, and Feb. 2, 2017, and could have been purchased directly from ADM Animal Nutrition or through one of three distributors including: Midwest Fertilizer, Inc. in Iola, Kansas; CW Feeds in Wichita, Kansas and Northtown Ace in Mountain Grove, Missouri.

ADM Animal Nutrition received reports from two customers claiming this feed may have resulted in death loss on their respective farms. The company immediately began investigating and initiated the recall upon receiving confirmation that the feed contained elevated levels of monensin due to a temporary breakdown in the packaging process, which has now been corrected. ADM has been in direct contact with the distributors involved in this recall, and all product has been removed from retail shelves. ADM is also working directly with the customers involved. (more…)

For Immediate Release

June 20, 2017

Contact

Consumers

JFC International Inc.
  consserv@jfc.com
 1-800-633-1004

Announcement

JFC International Inc. of Los Angeles, CA is voluntarily recalling a rice seasoning product because it was found to be missing the English Product Label for sale in the United States.   In addition, due to the missing English label, the product has undeclared Wheat, Soybean, and Fish (Bonito) allergens.  People who have allergies to wheat, soybeans, or fish (bonito) run the risk of a serious life-threatening allergic reaction if they consume the product.  No illnesses have been reported to date in connection with this problem. (more…)