Recall Report: Supplements May Contain Anabolic Steroids

This week saw a recall on nutritional supplements, recalls on chicken salad products, recalls on chandeliers, recalls on naan bread, recalls on insulin cartridge holders, recalls on CLIF bars, recalls on ATAR extension cables, and recalls on utility vehicles.

Details are below, courtesy of and

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Product Recalls for the Week of July 3, 2017:

  • Ultra-Sten and D-Zine Capsules: Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level.  These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall. Consumption of products containing derivatives of anabolic steroids may cause serious liver injury and other adverse health consequences, including kidney injury, increased risk of heart attack and stroke, decreased high-density lipoprotein (HDL) cholesterol levels, elevated blood pressure, aggressive behavior, male infertility, virilization in women (e.g., menstrual irregularities, deeper voice, increased body hair, baldness, etc.), and enlarged breasts and shrinkage of the testes in men. Patients with underlying cardiac, hepatic, or prostate conditions may be at higher risk for adverse reactions than otherwise healthy users. To date, Hardcore Formulations has not received any reports of these or any other illnesses or injuries related to Ultra-Sten or D-Zine. Ultra-Sten and D-Zine capsules are marketed as dietary supplements for body-building and are packaged  in 90-count bottles, with the bar code 7-48252-68763-0 (Ultra-Sten); 7-48252-86193-1 (D-Zine) and sold through retailers nationwide in the USA. This recall applies to all lot numbers and expiration dates of these products.  Ultra-Sten and D-Zine capsules were distributed nationwide in the USA to retailers from August 2014 to May 2017. Consumers who have Ultra-Sten and D-Zine products should stop using them, return them to their place of purchase or discard in accordance with state and local ordinances for disposal of drug products. Recall Date: 6/29/2017
  • Chicken Salad Products: Willow Tree Poultry Farm is recalling approximately 440 pounds of tuna salad products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced. The product contains tuna, a known allergen which is not declared on the product label and the packing was mislabeled as chicken salad product. The buffalo style chicken products were produced on June 27, 2017. Products subject to recall include 12.5-ounce individual plastic containers of “buffalo style chicken salad.” The products subject to recall bear establishment number “P-8827” inside the USDA mark of inspection. These items were shipped to Whole Foods Market locations in Connecticut, New Jersey and New York. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. Recall Date: 7/1/2017
  • Crystal Chandeliers: Lumicentro International S.A. is recalling crystal chandeliers because the halogen bulbs sold with the chandeliers can melt parts of the fixture, posing fire and burn hazards. The recall involves Hampton Bay 3-Light Crystal Chandeliers and Home Decorators Collection 4-Light Crystal Chandeliers.  The Hampton Bay 3-light chandelier has model number 03179-4 and the Home Decorators collection’s model number is 19161-4. The model numbers can be found on the top of the unit. The chrome ceiling fixtures have dangling crystals, weigh about 16 pounds and have three or four 50-watt halogen bulbs. Recalled chandeliers were sold exclusively at Home Depot stores in Puerto Rico and U.S. Virgin Islands sold the Hampton Bay 3-Light Crystal chandeliers from September 2013 through February 2017. Home Depot stores nationwide sold the Home Decorators Collection 4-Light Crystal chandeliers from October 2015 through February 2017. Consumers should immediately stop using the recalled chandeliers and contact Lumicentro Internacional S.A. for a free upgrade kit which includes 5 watt LED bulbs, suction cup, upgraded installation manual and new warning labels. The new labels identify that the fixture is only rated for LED bulbs with a maximum of 6.5 allowable wattage. Recall Date: 7/5/2017
  • Anarkali Peshawari Naan Bread: Raja Foods LLC is recalling its 15-ounce package of “ANARKALI PESHAWARI NAAN” because they may contain undeclared MILK. People who have allergies to MILK run the risk of serious or life-threatening allergic reaction if they consume these products. The recalled “ANARKALI PESHAWARI NAAN” were distributed nationwide in retail stores. The product comes in a 15-ounce plastic package marked “ANARKALI PESHAWARI NAAN” on the front of the bag. The manufacturing date and expiry date are on the back side of the bag. The dates are ink jetted and formatted as Year/Month/Date. One illness has been reported to date in connection with this problem. The complaint occurred in New Jersey and was reported to us through the United States Food and Drug Administration (FDA.) The recall was initiated after it was discovered that the MILK containing product was distributed in packaging that did not reveal the presence of MILK. Consumers who have purchased “ANARKALI NAAN” are urged to return them to the place of purchase for a full refund. Recall Date: 7/5/2017
  • CLIF® Builder’s® Bar: Clif Bar & Company is initiating a voluntary recall of CLIF® BUILDER’S® Bar Chocolate Mint flavor, and CLIF Kid Zbar® Protein Chocolate Mint and CLIF Kid Zbar® Protein Chocolate Chip flavors due to possible presence of undeclared peanuts and some tree nuts, including almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, walnuts and coconuts. Clif Bar & Company is taking this precautionary safety step for people who are allergic to peanuts and these listed tree nuts. People with an allergy to peanuts and these specific tree nuts run the risk of a serious or life-threatening allergic reaction. The company is strongly advising consumers who have peanut and these specific tree nut allergies not to consume these bars. The affected products are sold in retail stores and online throughout the U.S. The voluntary recall applies to products in all pack sizes and individual bars meeting the criteria found in the attached table. The affected “Best By” dates can be found on the back of individual packaging or caddies. The company is asking consumers to return product to the store where purchased to request an exchange or full refund if there is an allergy concern. Affected product should then be discarded in a secure place and not consumed. Recall Date: 7/5/2017
  • Insulin Cartridge Holders: Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. NovoPen Echo® is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low. Patients using an affected pen may want to check their blood sugar level more frequently until receiving a new cartridge holder. Patients should contact their health care provider if they believe they’re experiencing hyperglycemia. The affected batches were distributed between 8/1/2016 – 6/22/2017 to distributors, sales representatives and replacement programs for further distribution to pharmacies, healthcare providers and patients nationwide. Replacement cartridge holders will be provided for NovoPen Echo® from the following batches: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, and FVG8135. Novo Nordisk has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date. In the United States, people with diabetes using a NovoPen Echo® from one of the affected batches listed above are instructed to call Novo Nordisk to get a replacement cartridge holder. Recall Date: 7/5/2017
  • Cub Cadet 2016 Challenger Utility Vehicles: Hisun Motors Corp. U.S.A. is recalling Cub Cadet 2016 Challenger utility vehicles because air in the brake system can cause brake failure, posing a crash hazard to the user or bystander. This recall involves four-wheel drive Cub Cadet 2016 Challenger utility vehicles. Model numbers included in the recall are: CX500 (37AW7CKD010, 37AW7CKD710, 37AW7CLD010, 37AW7CLD710, 37AW7CMD710, 37AW7CND710); CX700 (37AX7CKD010, 37AX7CKD710, 37AX7CLD010, 37AX7CLD710, 37AX7CMD710, 37AX7CND710); and CX750 Crew(37AY8CKD710, 37AY8CLD710, 37AY8CMD710, 37AY8CND710). The utility vehicles were sold in yellow, red, blue and camouflage. The recalled vehicles were manufactured between March 2016 through November 2016. A label located under the driver’s seat lists the model number and the month and year of manufacture. Recalled utility vehicles were sold at Independent Cub Cadet dealers nationwide from March 2016 through May 2017. Consumers should immediately stop using the recalled vehicles and contact an authorized Cub Cadet dealer or Cub Cadet customer service to arrange for a free repair. Recall Date: 7/6/2017
  • ATAR Extension Cables: The ATAR cable is an extension cable with connector(s) on both sides, designed to connect with various receptacles or cables/leads, depending on the instrument being used. The extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker. During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.  This event resulted in cable malfunction, causing interruption of the pacing system. A full list of recalled extensions can be found on the U.S. Food and Drug Administration’s product page. Oscor received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries. No deaths were reported; however the risk for possible injury is a concern if the cable separates during use. Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Recall Date: 7/6/2017