MAXAM LABORATORIES OF HOOD RIVER, OREGON ISSUES WORLDWIDE RECALL DUE TO MISBRANDING, ADULTERATION, AND/OR BEING CONSIDERED UNAPPROVED NEW DRUGS Company Contact: James G. Cole (541) 436‐0874 FOR IMMEDIATE RELEASE – November 16, 2015 ‐ Maxam Laboratories and James G. Cole, Inc. of Hood River, Oregon are recalling ALL products distributed by Maxam Laboratories, ASN, or Maxam Nutraceutics because the products are misbranded, adulterated, and/or considered unapproved new drugs. The company had previously notified direct customers of this recall via email on March 6, 2015. The company recalled these products because it was ordered to do so by the United States District Court for the District of Oregon because these products were found by the Court not to have been manufactured in compliance with all of the manufacturing practices required by federal law. The company has received no reports of any injury, or illness caused by use of the products or any other adverse events to date. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Maxam products are used orally in spray form and bear the Maxam label. The ASN products are in capsule or powdered form and bear the ASN label. The ASN and Maxam products were distributed directly to Maxam customers worldwide or sold from the website www.maxamlabs.com. The recalled products are listed in the table below and identified in the attached labels. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this press release. Maxam asks that anyone possessing any Maxam or ASN products should destroy them by pouring them down the sink or into a toilet bowl, or by returning the products to the following address where they will be destroyed: P.O. Box 1277, Hood River, OR 97031. If any user of a Maxam or ASN product has experienced any adverse reaction or quality problems, this may be reported to FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax: Complete and submit the report Online: www.fda.gov/medwatch/report.htm • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1‐800‐ 332‐1088 to request a reporting form, then complete and return to the address on the pre‐addressed form, or submit by fax to 1‐800‐FDA‐0178.
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MAXAM LABORATORIES OF HOOD RIVER, OREGON ISSUES WORLDWIDE RECALL DUE TO MISBRANDING, ADULTERATION, AND/OR BEING CONSIDERED
UNAPPROVED NEW DRUGS
Company Contact: James G. Cole (541) 436‐0874 FOR IMMEDIATE RELEASE – November 16, 2015 ‐ Maxam Laboratories and James G. Cole, Inc. of Hood River, Oregon are recalling ALL products distributed by Maxam Laboratories, ASN, or Maxam Nutraceutics because the products are misbranded, adulterated, and/or considered unapproved new drugs. The company had previously notified direct customers of this recall via email on March 6, 2015. The company recalled these products because it was ordered to do so by the United States District Court for the District of Oregon because these products were found by the Court not to have been manufactured in compliance with all of the manufacturing practices required by federal law.
The company has received no reports of any injury, or illness caused by use of the products or any other
adverse events to date. Consumers should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using this drug product.
Maxam products are used orally in spray form and bear the Maxam label. The ASN products are in capsule or powdered form and bear the ASN label. The ASN and Maxam products were distributed directly to Maxam customers worldwide or sold from the website www.maxamlabs.com. The recalled products are listed in the table below and identified in the attached labels. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this press release. Maxam asks that anyone possessing any Maxam or ASN products should destroy them by pouring them down the sink or into a toilet bowl, or by returning the products to the following address where they will be destroyed: P.O. Box 1277, Hood River, OR 97031.
If any user of a Maxam or ASN product has experienced any adverse reaction or quality problems, this
may be reported to FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax:
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1‐800‐
332‐1088 to request a reporting form, then complete and return to the address on the pre‐addressed
form, or submit by fax to 1‐800‐FDA‐0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Consumers with questions may contact the company at (541) 436‐0874 from 9 a.m. to 5 p.m. Pacific Time Zone, Monday‐Friday.
MAXAM BRAND- ALL LOTS & ALL SIZES Label (Y/N)
AD Nutritional Support for a Positive Outlook Y
AFX Nutritional Support for Healthy Cellular Function Y
ANANDA Nutritional Support for Emotional & Muscular Well‐Being Y
ANAVONE Nutritional Support for Healthy Stress Management Y
ANACORT 5 Methyl 7 Methoxyisoflavone Y
BCAA Branched Chain Amico Acids. Nutritional Support for Muscle Growth Y
BIOGUARD Nutritional Support for Gastrointestinal Health Y
B‐MAX Nutritional Support for Endogenous B Vitamins Y
CELLAFLEX Nutritional Support for Joints, Skin & Connective Tissue Y
CO‐Q10 Nutritional Support for Endogenous Co‐Q10 Y
CREOCELL Nutritional Support for Endogenous Creatine Phosphokinase (CPK) Y
CYTOMUNE Nutritional Support for Healthy Immune Function Y
C‐60 Fullerine. Nutritional Support for Antioxidant Activity Y
DEEP SLEEP N
ENDOTROPIN N
FGF Fibroblast Growth Factor. Nutritional Support for Endogenous FGF Y
GTF N
HCG Nutritional Support for Endogeous HCG Y
HIGH CHI N
H‐PLUS H‐Plus Hydrogen. Nutritional Support for Health Cellular Antioxidant Activity Y
KETOPLEX Nutritional Support for Women's Hormonal Health Y
LIV Nutritional Support for Liver Health Y
MAXATROPIN Nutritional Support for Hormonal Health in Men & Women Y
MYOTROPIN Myostatin Inhibitor. Nutritional Support for Healthy Muscle Regeration Y
NADH Nutrional support for Healthy Mitochondrial Function Y
NATURAL PASSION N
NERVEX Nutritional Support for Healthy Nerve Function Y
NEUROGEN Nutritional Support for Healthy Brain Function Y
OSTEOREN Nutritional Support for Health Teeth & Bones Y
OXYCHARGE Nutritional Support for Aerobic Metabolism & Endurance Y
OXYTOCIN Nutritional Support for Endogenous Oxytocin Y
PC3 Nutritional Support for Toxin & Waste Elimination 3 Ways Y
PCA Nutritional Support for Natural Toxin & Waste Elimination Y
PCR N
PHP Paleolithic Human Probiotics. Probiotic & Post Biotic Y
PINEAL Nutritional Support for Pineal Health Y
SAMe Nutritional Support for Endogenous SAMe Y
SERENITY N
TELONGMERASE Nutritional Support for Telomere Health Y
TRANQUILITY Nutritional Support for Relaxation Y
TRP Nutritional Support for Healthy Thyroid Function Y
XOMATROPIN Nutritional Support for Endogenous HGH Y
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BCAA BRANCHED CHAlN
AMINO ACIDS Nutritional Sup~ for
Muscle GrOWth·
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