FDA Advances Fight Against DEG-EG Contamination With Multiple Warning Letters

The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially lethal contaminant since March — and nine on the issue just this week.

Eleven companies that received warning letters this year are foreign manufacturers on an import alert that prevents their products from entering the U.S. Eight of the 22 are for U.S. companies.

An update from CDER Director Patrizia Cavazzoni explains that the agency has “no indication these contaminated products have entered the U.S. drug supply chain” but that the FDA is “making every effort to prevent contaminated drug products from entering the U.S. market.”

Read the FDA’s statement regarding the DEG-EG warning letters here.

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