FDA Warns of Potential Baclofen API Contamination

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FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

FDA is warning drug compounders about possible contamination of lots of baclofen API manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City, Zhejiang Province, China. According to the agency, certain lots “may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs.”

Taizhou, a manufacturer of APIs for repackagers and distributors, confirmed to FDA that their baclofen was not suitable for use in injectable drugs because of the level of controls in the manufacturing process. FDA states that the affected API may potentially cause safety risks to US patients who use injectable drugs compounded with the affected API, especially if administered directly into the spinal column. FDA states that the baclofen may also be at risk for endotoxin or microorganism contamination. 


Source: FDA