Showing posts with label . recalled. Show all posts
Showing posts with label . recalled. Show all posts

Saturday, December 12, 2015

Fuel Up Plus and Fuel Up High Octane recalled

Reesna Inc., Canoga Park, CA, is voluntarily recalling all lots of Fuel Up Plus and Fuel Up High Octane particularly distributed in August 2015 due to containing undeclared hydroxythiohomosildenafil, an analogue of sildenafil. Sildenafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Fuel Up an unapproved drug. The problem was found after FDA sampled the product and the results were positive for undeclared hydroxythiohomosildenafil.
Hydroxythiohomosildenafil is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because sildenafil 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. No illnesses or injuries have been reported to the company to date in connection with this product.
Fuel Up is marketed as a dietary supplement sexual enhancer for men. The product was sold to distributors and retail stores nationwide and via internet sales.
Reesna Inc. is notifying its customers by email and telephone. Consumers should not consume Fuel Up and should return it immediately to the place of purchase for a full refund. Reesna is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers.
Consumers should contact their physician if they have experienced any problems that may be related to taking this product. Consumers with questions should contact Romy Navarro at 818-576-0576, Monday through Friday, 9:00 am to 5:00 pm, PST.
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.

  • Label, Fuel Up High Octane, 10 capsules
  • Label, Fuel Up High Octane, single
  • Label - Fuel  Up High Octane,  5 capsules
  • Label, Fuel Up Plus, 5 capsules
  • Label,  Fuel Up Plus, 10 capsules

Tuesday, November 10, 2015

Natureal, a weight loss supplement was recalled

Inaffit, LLC is voluntarily recalling all lots of Natureal light green and dark green capsules to the consumer level after FDA laboratory testing found Natureal to contain sibutramine.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established. This product may also interact in life-threatening ways with other medications a consumer may be taking.
The product is used as a weight loss dietary supplement and is packaged in clear bottle with light green and dark green capsules. The affected Natureal product includes lots Manufactured 3/12/2015 Expiration Date 3/11/2017 which have been distributed from the Natureal office, 14707 South Dixie Highway, Suite 213, Palmetto Bay, FL 33176 and nationwide to consumers via internet www.naturealfls.com.
Inaffit, LLC is notifying its customers by Email and is arranging for return. Consumers who are currently in possession of recalled Natureal light green and dark green capsules should stop using the product and discard. Inaffit, LLC switched to a U.S. Food and Drug Administration Registered Facility to manufacture their dietary supplements and changed the Natureal packaging to a clear bottle with clear capsules.
Consumers with questions regarding this recall can contact Inaffit, LLC by email atreturns@naturealfls.com. 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.
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
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.