cGMPs

FDA Warns Compounders of Contaminated APIs

Source: FDA

Dec 11, 2015

The U.S. FDA has advised that certain lots of baclofen active pharmaceutical ingredient from Taizhou Xinyou Pharmaceutical & Chemical may be contaminated with particulates and should not be used to compound sterile injectable drugs.

According to the FDA alert, Taizhou, located in Zhejiang Province, China, manufactures APIs for repackagers and distributors, some of which sell these products to compounding facilities in the United States. The affected API could pose "serious safety risks" for U.S. patients who use or receive injectable drug products compounded with the affected baclofen, especially when administered into the spinal column.

Baclofen is an FDA-approved skeletal muscle relaxant and antispasmodic, often used to relieve Multiple Sclerosis pain. Contaminated baclofen may clog pumps used to administer the medication, also potentially introduce harmful endotoxin or microorganisms into the body.

 Read the FDA alert