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Recall of Falcon Labs Food Supplements due to Presence of Illegal Steroids and Stimulants and Lack of Traceability

Thursday, 8 March 2018

Summary
Category 1:

For Action

Alert Notification:

2018.09

Product:

Falcon Labs Food Supplements

Batch Code:

All Falcon Labs products, all batch codes, all best before dates, all pack sizes.

Country Of Origin:

Unknown

Message:

The FSAI has detected 1,3-Dimethylamylamine (1,3-DMAA), also known as methylhexaneamine (MHA),  in Falcon Labs OXYBURNPRO and Falcon Labs SUPERCLEN.  Methasterone was detected in Falcon Labs SUPERDRIVE.  As it is not known where these products have been manufactured, the FSAI cannot have confidence that any Falcon Labs product is safe to consume.

Nature Of Danger:

1,3-DMAA, also known as methylhexaneamine (MHA) is an unauthorised stimulant, and methasterone an unauthorised steroid.

Consumption of 1,3-DMAA can cause an acute temporary increase in blood pressure, which may lead to shortness of breath, tightening of the chest and the risk of heart attack or cerebral haemorrhage. Methasterone is considered hepatotoxic and has been associated with a number of cases of cholestatic liver injury.

1,3-DMAA was previously authorised as a nasal decongestant, but later withdrawn from the market. Methasterone is an orally active anabolic-androgenic steroid, which has never been authorised as a medicine, but has been previously sold on the black market under the name Superdrol.

Furthermore, the business address printed on the product label and on supplier invoices are not genuine. As it is not known where the products are manufactured, the FSAI cannot have confidence that any Falcon Labs product is safe to consume.

Action Required:

Inspectors:

Environmental health officers (EHOs) are requested to check food businesses to determine if Falcon Lab products are available for sale. If found, EHOs should seize, remove and detain the products off site; also oversee a recall, ensuring a point-of-sale notice is displayed in store and on websites if sold online.  Please notify the FSAI (foodincidents@fsai.ie) of the name and address of any suppliers of Falcon Labs products.

Manufacturers, wholesalers, distributors, caterers & retailers:

Food businesses, including online retailers, currently selling Falcon Lab products must immediately remove these products from sale and contact their supervising environmental health officer (or foodincidents@fsai.ie) so that any remaining stock can be removed.  Food businesses that have sold Falcon Lab products to consumers must display a point-of-sale notice in store and on websites if sold online, to inform consumers that Falcon Labs products are being recalled and the reason why.

Consumers:

Consumers should not purchase or consume any Falcon Labs products. If you have consumed Falcon Labs products and are feeling unwell you should seek medical advice. The FSAI is requesting that consumers who have purchased a Falcon Labs product inform the FSAI where they purchased it by emailing foodincidents@fsai.ie.

Falcon Labs