Recalls & Warnings
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Posted August 16, 2013
Maker of Energy, Weight Loss, Sleep and Vitamin D Supplements Warned for Manufacturing Violations
These violations include failure to establish dietary supplement specifications for identity, purity, strength, failure to establish required specifications for certain steps in the manufacturing process, and failure to use sanitary handling procedures during filling, packaging, and labeling operations.
The FDA also noted that N.V.E.'s established procedure for product complaints is inadequate because it lacks details and directions for documenting and following up on product complaints.
Between October 2011 and June 2012, the company received 29 health related complaints - including a complaint of a heart attack, a possible allergic reaction, jittery, sick feeling, and a rash, associated with the use of Stacker 2, Stacker 2 XPLC, Black Jax, Yellow Hornet, Extra Strength Xtra Energy Shot, Extra Strength 6 Hour Energy Shot, Extra Strength Extreme Energy Shot, Stacker 3 and Stacker 3 XPLC - but was unable to provide sufficient information about these complaints to the FDA.
In addition, Stacker 2, Stacker 2 XPLC, Black Jax, Yellow Hornet, Extra Strength Xtra Energy Shot, Extra Strength 6 Hour Energy Shot, Extra Strength Extreme Energy Shot, Stacker 3 and Stacker 3 XPLC, DIET APPULOSS, 7-Phenyl Stack Diet and Energy, Extreme Energy Kickin Classic Zero, SLEEP EASE Shot and Vitamin D3 Shot were found to be misbranded because the labels did not provide information required by federal regulations.
To read the FDA's warning, use the link below.