FDA Finds Prozac in USPlabs Supplement, but Company Claims it’s a Counterfeit

From this extended article

A dietary supplement firm long on the US Food and Drug Administration's (FDA) enforcement radar is again in the agency's sights after regulators claim they found fluoxetine, the active ingredient in Prozac, in one of the company's former fitness products.

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In December 2012, FDA sent the company a Warning Letter regarding three of its products: Jack3D, Super Cissus and Oxy Elite Pro. The company's manufacturing operations did not meet federal regulations for good manufacturing practices (GMPs), FDA said. In addition, the company's Super Cissus product was cited by regulators as being marketed for claims restricted for approved pharmaceuticals, and was therefore misbranded.

In April 2013, the company's Jack3D and Oxy Elite Pro supplements were again the target of an FDA Warning Letter after the agency said they contained dimethylamylamine (DMAA), an ingredient linked to cardiovascular adverse events.

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Now USPlabs is again facing FDA scrutiny after agency regulators said they found an undeclared drug ingredient in the since-discontinued product.

On 28 February 2015, FDA issued a "public notification" that USPlabs' Oxy Elite Pro containing fluoxetine, the active ingredient in Prozac, and should not be used by consumers.

"This product was identified by FDA during an examination of international mail shipments," FDA wrote in its notice.

In a statement, USPlabs said the product in question was counterfeit, and that, “Media reports saying that a company product contains Prozac are false.