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By Bronwyn Mixter
Dec. 10 — The FDA Dec. 9 said it is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by China-based Taizhou Xinyou Pharmaceutical & Chemical Co. may be at risk for contamination with particulates and shouldn't 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 U.S., the Food and Drug Administration said. The agency said it contacted Taizhou through its U.S. agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures isn't suitable for use in injectable drugs.
The FDA said it recommends that no baclofen API from Taizhou be used to manufacture or compound any injectable drugs. Baclofen is a muscle relaxant.
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, the FDA said.
The agency also said there is a potential risk that the baclofen API may be contaminated by endotoxin or microorganisms.
The FDA said it is continuing to investigate this incident. Adverse events associated with the affected baclofen API should be reported to the FDA's MedWatch Adverse Event Reporting program, the agency said.
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