US/Silver Spring:
MyNicNaxs, LLC, a Deltona, Florida establishment, has recalled all lots of various Dietary Supplements due to suspected presence of Diclofenac, Phenolphthalein, Sibutramine and/or Sildenafil, all controlled substances and undeclared active pharmaceutical ingredients (“APIs”). The presence of Diclofenac, Phenolphthalein, Sibutramine and/or Sildenafil in the recalled Dietary Supplements renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Due to their ingredients, these Supplements all pose serious health and safety hazards. FDA: http://ht.ly/zYCx30kVBsI
Direct link: https://www.fda.gov/Safety/Recalls/ucm613197.htm
Additional information:
The US Food and Drug Administration (“FDA”) reports the following over-the-counter (“OTC”) drugs are subject to this recall (in alphabetical order):
Filed under: Diclofenac, Dietary Supplements, Drugs, Food & Drink, Labeling or regulatory issues, Phenolphthalein, Sibutramine, Sildenafil, US FDA | Tagged: dietary supplement, FDA, increased risk of Heart Attack, MyNicNaxs, nutritional supplement, Recalls Direct RIN: 10388-2018, suspected presence of Sibutramine, suspected-presence-of-Diclofenac, suspected-presence-of-Phenolphthalein, suspected-presence-of-Sildenafil, unapproved drug hazard, US Food and Drug Administration | Leave a comment »