Wyked Labs Issues Voluntary Nationwide Recall of Eight Dietary Supplement Products Due to Presence of Prohormone

Wyked Labs Issues Voluntary Nationwide Recall of Eight Dietary Supplement Products Due to Presence of Prohormone

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Wyked Labs Issues Voluntary Nationwide Recall of Eight Dietary Supplement Products Due to Presence of Prohormone Ingredients
Contact:
Consumer:
Wyked Labs
Eric Dubois
407-679-7986 407-679-7986
Email: [email protected]
FOR IMMEDIATE RELEASE — December 12, 2014 — Winter Park, FL — Wyked Labs of Winter Park, Florida is voluntarily conducting a nationwide recall of all lot codes of the following products (collectively, the “Recalled Products”) to the user/consumer level:
Wyked Labs Ml-Alpha
Wyked Labs M14-Ment
Wyked Labs Halo-70
Wyked Labs 7-Ment Alpha
Wyked Labs Estrastain
Wyked Labs Swoll-250
Formexx Black (an Anabolic Science Labs product)
Slim X Lean (an Anabolic Science Labs product)
This recall is being conducted due to the presence of ingredients that the Food and Drug Administration (“FDA”) has stated do not meet the requirements of the Dietary Supplement Health and Education Act of 1994. Specifically, the Recalled Products are prohormone products or are otherwise adulterated. FDA has opined that prohormones are synthetic steroids that bear a similarity to anabolic steroids. It is FDA’s position that the ingredients in the products are not properly dietary ingredients that may be present in dietary supplements. Wyked Labs’ decision to implement this recall should not be construed as an admission that its sale of these products was in violation of the law. Wyked Labs is undertaking this voluntary recall solely out of an abundance of caution and in deference to FDA’s stated concerns.
Use or consumption of products containing methylated anabolic steroids may cause acute liver injury, which is known to be a possible harmful effect of using steroid¬containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. To date, Wyked Labs has not received reports of these or any other adverse effects related to this recall.
The Recalled Products were distributed nationwide to various nutritional supplement retail outlets and via the internet. The Recalled Products can be identified as follows:
Wyked Labs Ml-Alpha is packaged in a white plastic bottle containing 60 capsules.
The product can be identified by the brand name Wyked Labs and the product name Ml¬ Alpha, Mega Mass Builder.
Wyked Labs M14-Ment is packaged in a white plastic bottle containing 90 capsules.
The product can be identified by the brand name Wyked Labs and the product name
M14-Ment, Advanced Mass Builder.
Wyked Labs Halo-70 is packaged in a white plastic bottle containing 60 capsules. The product can be identified by the brand name Wyked Labs and the product name Halo-70, Mega Mass Builder.
Wyked Labs 7-Ment Alpha is packaged in a white plastic bottle containing 90 capsules.
The product can be identified by the brand name Wyked Labs and the product name 7- Ment Alpha, Advanced Mass Builder.
Wyked Labs Estrastain is packaged in a white plastic bottle containing 60 capsules.
The product can be identified by the brand name Wyked Labs and the product name
Estrastain, Pro-Anabolic Mass and Hardening Complex.
Wyked Labs Swoll-250 is packaged in a black plastic bottle containing 90 capsules. The product can be identified by the brand name Wyked Labs and the product name Swoll- 250, Super Mass Builder.
Formexx Black is packaged in a black plastic bottle containing 60 capsules. The product can be identified by the brand name Anabolic Science Labs (ASL) and the product name Formexx Black.
Slim X Lean is packaged in a clear plastic bottle containing 56 capsules. The product can be identified by the brand name Anabolic Science Labs (ASL) and the product name.
Wyked Labs is notifying its distributors by a formal recall notification and arranging for a return of all Recalled Products. The manufacture and distribution of all of the Recalled Products has been ceased. Consumers, distributors, and retailers with any of the Recalled Products should STOP USING them and immediately return them 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 Eric Dubois, Chief Executive Officer of Wyked Labs, by phone at 1-407-679-7986 1-407-679-7986 or by email at [email protected], Monday through Friday from 9 am to 5 pm Eastern Standard Time.
Adverse reactions or quality problems experienced with the use of the Recalled Products 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 1-800-332-1088 FREE 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
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Photo: Product Labels
Recalled Product Photos Are Also Available on FDA’s Flickr Photostream.

* We believe that none of the products being recalled were processed or offered through the national office.

* We strongly encourage you to notify your agencies within one business day from receipt of this notice.

* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.

* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
For full details on the recall, please visit: http://www.fda.gov/Safety/Recalls/ucm432880.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

If you have questions, please contact Wayne Melichar, Food Safety Manager, at [email protected] or 312.629.7263.