Chaotic Labz Issues Voluntary Nationwide Recall of Mayhem Dietary Supplement Due to Undeclared Dexamethasone and Cyproheptadine

Chaotic Labz, Atkins, Arkansas, is voluntarily conducting a nationwide recall of Mayhem dietary supplement capsules, Lot #CLM061114 with an expiration date of 06/2016, to the user/consumer level. Mayhem’s intended use is as a bodybuilding supplement. FDA laboratory analysis found that Mayhem Dietary Supplement contains undeclared dexamethasone, a prescription corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment, making this an unapproved drug.

Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness. In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications. To date, Chaotic Labz has not received reports of these adverse effects related to this recall.

Mayhem is packaged in a clear bottle with yellow capsules associated with Lot #CLM061114 with an expiration date of 06/2016. The product can be identified by the brand known as Chaotic Labz and product name Mayhem, Appetite for Construction. This product was distributed nationwide to various Nutritional Supplement Retail Outlets and via the internet.

Chaotic Labz is notifying its distributors and customers by a formal recall notification and arranging for a return of all recalled products. Distribution of Mayhem will also be halted. Consumers, Distributors, and Retailers that have any of the recalled product should STOP USING and return immediately to the place of purchase. Contact your health care professional if you have experienced any adverse effects.

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USFDA takes action against dietary supplement manufacturer BioAnue Laboratories of Rochelle, Georgia, USA

25 AUG 2014

A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber. 

BioAnue’s products were sold as supplements but were unapproved new drugs because they were marketed as treatments for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes, without approval from the FDA, according to the court order. The order was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia.   

The defendants did not take appropriate corrective action in response to a FDAwarning letter issued on Feb. 9, 2012, involving the marketing of the firm’s dietary supplements as unapproved new drugs. A follow-up FDA inspection in August 2012 revealed that BioAnue was also manufacturing products that were not in compliance with FDA’s current good manufacturing practice requirements for dietary supplements.

The permanent injunction prohibits the manufacture or distribution of products until the defendants hire independent experts to assist in bringing the firm’s manufacturing practices and labeling into compliance with the law.

District Judge Marc T. Treadwell said, in the court order, that the government was able to provide evidence that the defendants sold unapproved new drugs and failed to follow FDA’s current good manufacturing practice regulations for dietary supplements.

“The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.”

The defendants’ products include: TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage.