The FDA is warning compounders to be on the alert for batches of baclofen APIs manufactured at the Taizhou Xinyou Pharmaceutical and Chemical plant in China because of the risk of contamination with particulates.
The FDA MedWatch alert said the products shouldn't be used to compound sterile injectable drugs and asks that health professionals in the fields of anesthesiology, pain management, neurology and pharmacy to be on the alert for any such batches made at the plant based in Taishou City, Zhejiang Province, China.
Taizhou manufactures APIs for repackagers and distributors, some of which sell their products to compounders in the U.S., the FDA said in the alert. Agents who contacted Taizhou said the company confirmed that due to the level of controls in the plant the baclofen API it made is unsuitable for use in injectable drugs.
Patients who are injected with any drugs made from the compound may be at serious risk, especially if an injection is administered directly to the spinal column, the agency said. There is also a potential risk that batches of baclofen may be contaminated by endotoxin or microorganisms.
The FDA said its investigation is ongoing and recommends that no baclofen from Taizhou be used.
Early last month, it was reported the FDA cited a Pfizer ($PFE) plant in China while U.K. regulators recently found shortcomings at a GlaxoSmithKline ($GSK) plant there. About 40 facilities in China are currently on the regulatory agency's import ban list.
- here's the FDA MedWatch notice