News & Press: Patient Safety

FDA Warns of the Potential Contamination of Taizhou's Baclofen API

Wednesday, December 9, 2015  
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Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination

The FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City, Zhejiang Province, China, may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs. Taizhou manufactures APIs for repackagers and distributors, some of which sell these products to compounding facilities in the United States. FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in injectable drugs. Based on available information, the affected API may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with the affected baclofen, especially when administered directly into the spinal column. FDA is continuing to investigate this incident.

Read the FDA MedWatch safety alert, including a link to the firm’s Press Release, here.


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