FDA alerted compounding pharmacies in early December that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical and Chemical Company in Taizhou City, China, may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs. 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, as it may contain particulate matter. The use of baclofen API contaminated with particulate matter can result in serious injury if injected directly into the spinal column and may also clog pumps used to administer the medication. There is also a potential risk that the baclofen API may be contaminated by endotoxin or microorganisms.
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