This is a reprint of an FDA Alert.

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Contact:

Consumer:

Chaotic Labz 1-479-223-2677

FOR IMMEDIATE RELEASE – November 14, 2014 – 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.

Consumers with questions regarding the recall can contact Cordy Hooten, Owner of Chaotic Labz, by phone number at (479) 223-2677 or email at contact.chaoticlabz@gmail.com, Monday – Friday from 9am-5pm central standard time. No other products distributed by Chaotic Labz are subject to recall.

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 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.