Apparently the FDA's crackdown on foreign outsource drug manufacturers arising from the revelation that certain pharmaceutical products found to be contaminated with NDMA, NDEA and other N-Nitros made offshore and sold in the United States, has led to the discovery that other pharmaceutical products produced by offshore manufacturers are also potentially contaminated with Diethylene Glycol (DEG), a lethal toxin.
Thus far, three offshore pharmaceutical contract manufacturers have received warning letters from the FDA related to DEG found in lots of product. All three of these manufacturers are major importers to the United States to whom many U.S. drug makers outsource production of various prescription as well as over the counter drugs.
It is safe to assume that more recalls like those that have recently been issued related to products contaminated with NDMA, NDEA and other N-Nitro Substances (Valsartan and Zantac et.al.) will be forthcoming soon related to DEG Contamination.
|Sunstar Guangzhou Ltd.||CGMP/Finished Pharmaceuticals/Adulterated||1/22/2020|
|Dental-Kosmetik GmbH & Co. KG||CGMP/Finished Pharmaceuticals/Adulterated||1/16/2020|
|Huaian Zongheng Bio-Tech Co., Ltd||CGMP/Finished Pharmaceuticals/Adulterated||1/9/2020|
What Is Diethylene Glycol?
Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, poisonous, hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used in antifreeze solutions and as a solvent.
DEG is produced by the partial hydrolysis of ethylene oxide. Depending on the conditions, varying amounts of DEG and related glycols are produced. The resulting product is two ethylene glycol molecules joined by an ether bond, Diethylene glycol is derived as a co-product with ethylene glycol and triethylene glycol.
DEG is highly toxic to humans as well as other animals.
Injuries Associated with Diethylene Glycol
Acute kidney injury often leading to death
Heart Damage including Heart Failure
Neurological Damage Brain Damage