1ViZN, L.L.C. Lehi, UT (4/24). Unapproved new dietary ingredient, adulterated: The Supplement Facts panel on the product label declares AMP as a dietary ingredient. (Velocity); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444390.htm

Applied Medical Resources Corp. Rancho Santa Margarita, CA (4/10). Inspected 11/3-12/16/14. QSR deviations, adulterated: Quality data were not adequately analyzed to identify causes of non-conformities and to identify corrective and preventive actions. For example, the firm received 94 complaints in 2014 related to the suction/irrigation malfunctions of the blue and red suction/irrigation buttons getting stuck and not turning off. This resulted in continuous suctioning, tissue injury, and/or fluid irrigation. Also it received complaints of the Kii Trocar blade not returning back to the trocar, trocar breakage, molding defect, and obturator/seal problem. The firm’s review of these complaints failed to adequately evaluate and investigate the non-conformities, etc. (devices are used in minimally invasive surgery, laparoscopy, cardiovascular/vascular, urologic and general surgery); FDCA 501(h), 21 CFR 820.100(a)(3), 820.198(c), 820.30(c)&(g), 803.50(a)(1).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm443692.htm

Beta Labs Newark, DE (4/24). Unapproved new dietary ingredient, adulterated: The firm offers for sale its Oxyphen XR Amp’d as a dietary supplement and the Supplement Facts panel on the product label declares 4-AMP (4-Amino methylpentane citrate)(Pochung Tea) as a dietary ingredient. (Oxyphen XR Amp’d); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444381.htm

Better Body Sports, LLC Ventura, CA (4/22). Unapproved new dietary ingredient, misbranded: The firm’s product Phoenix Extreme is labeled and/or offered for sale as a dietary supplement and its product labeling lists the substance R-beta-methylphenethylamine as a dietary ingredient. (Phoenix Extreme); FDCA 403(a)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444043.htm

Aaron Singerman Blackstone Labs, LLC Boca Raton, FL (4/24). Adulterated, unapproved new dietary ingredient: The firm’s Angel Dust is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (Angel Dust); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444383.htm

Brand New Energy, LLC Burbank, CA (4/24). Adulterated, unapproved new dietary ingredient: The firm’s Yellow Bullet AMP is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (Yellow Bullet AMP); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444412.htm

Core Nutritionals LLC Arlington, VA (4/24). Adulterated, unapproved new dietary ingredient: The firm’s AMP Citrate is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (AMP Citrate); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444395.htm

Genomyx LLC Riverside, CA (4/24). Adulterated, unapproved new dietary ingredient: The firm’s Evol is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (Evol); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444378.htm

Hi-Tech Pharmaceuticals, Inc. Norcross, GA (4/22). Unapproved dietary ingredient, misbranded: The firm’s Fastin-XR, Fastin Rapid Release, and Lipodrene Extended Release are labeled and/or offered for sale as dietary supplements and the product labeling lists the substance R-beta-methylphenethylamine as a dietary ingredient in the form of an extract of Acacia rigidula (leaves). Although the product labeling asserts that BMPEA is an extract of the botanical Acacia rigidula, FDA is not aware of evidence to support an assertion that BMPEA is, in fact, a constituent of this botanical. (Fastin-XR, Fastin Rapid Release, and Lipodrene Extended Release); FDCA 403(a)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444040.htm

Human Evolution Supplements, Inc. Hollywood, FL (4/22). Unapproved dietary ingredient, misbranded: The firm’s Core Burner Watermelon powder is labeled and/or offered for sale as a dietary supplement and its labeling lists the substance R-beta-methylphenethylamine HCl as a dietary ingredient in the Core Burner Proprietary Blend. (Core Burner Watermelon powder); FDCA 403(a)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444045.htm

Iron Forged Nutrition dba TGB Supplements Hopwood, PA (4/24). Adulterated, unapproved new dietary ingredient: The firm’s Contraband is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (Contraband); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444374.htm

Martin Avenue Pharmacy Naperville, IL (3/18). Inspected 6/30-7/21/14. Unapproved new drugs, GMP deviations, adulterated, misbranded: The investigator noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. Also, the firm produces domperidone products. Domperidone is not the subject of an applicable USP or National Formulary monograph, nor is it a component of an FDA-approved human drug product. The firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas, etc. (compounded drugs); FDCA 502(f)(1), 505(a), 501(a)(2)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm443248.htm

Nutrex Research, Inc. Oviedo, FL (4/24). Adulterated, unapproved new dietary ingredient: The firm’s Adipodex is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (Adipodex); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444414.htm

Powder City LLC York, PA (4/24). Adulterated, unapproved new dietary ingredient: The firm’s AMP Citrate is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (AMP Citrate); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444410.htm

Prime Nutrition Boca Raton, FL (4/24). Adulterated, unapproved new dietary ingredient: The firm’s PWO/STIM is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient. (PWO/STIM); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444386.htm

RPM Nutrition, LLC Norwalk, CT (4/24). Adulterated, unapproved new dietary ingredient: The firm’s Red Rum SS is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient (Red Rum SS); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444398.htm

Train Naked Labs LLC Palm Bay, FL (4/22). Unapproved new dietary ingredient, misbranded: The firm’s Critical FX and Sudden Impact are labeled and/or offered for sale as dietary supplements and the product labeling lists the substance R-beta-methylphenethylamine HCl as a dietary ingredient. (Critical FX and Sudden Impact); FDCA 403(a)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444047.htm

Tribravus Enterprises, LLC dba iForce Nutrition Vista, CA (4/22). Unapproved new dietary ingredient: The firm’s Conquer (Fruit Punch Slam and Raspberry Lemonade flavors) are labeled and/or offered for sale as dietary supplements and the product labeling lists the substance R-beta-methylphenethylamine as a dietary ingredient in the form of an extract of Acacia rigidula (leaves). The agency is unaware of any evidence to support an assertion that BMPEA is, in fact, a constituent of this botanical. (Conquer — Fruit Punch Slam and Raspberry Lemonade flavors) FDCA 403(a)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444041.htm

Vital Pharmaceuticals Weston, FL (4/24). Adulterated, unapproved new dietary ingredient: The firm’s VPX Redline White Heat (strawberry, fruit punch, and watermelon) and MD2 Meltdown is labeled and/or offered for sale as a dietary supplement and the Supplement Facts panel on the product label declares AMP Citrate (4-amino-2-methylpentane citrate) as a dietary ingredient (VPX Redline White Heat (strawberry, fruit punch, and watermelon) and MD2 Meltdown,); FDCA 402(f)(1)(B) and 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm444377.htm