Premature Infant Drug Curosurf Suspected of Contamination; FDA Issues Red Alert for Recall

The Ministry of Health and Welfare's Food and Drug Administration stated that this alert originated from drug recall messages issued by the Czech Republic and Italy on March 17th and 18th. The main reason was the risk of microbial contamination in the drugs "Curosurf 80mg/mL" and "Curosurf, 120mg, 240mg" manufactured by CHIESI FARMACEUTICI S.P.A.

The FDA's investigation found that the affected drug in Taiwan is "Curosurf Inhalation Suspension (衛署藥輸字第024768號)". A "red light" warning was recently issued, and drug recall information was simultaneously announced.

Liu Chia-ping, a senior technical specialist in the FDA's drug division, told CNA today that the importer, Hualien Biotech Pharmaceutical Co., Ltd., proactively reported receiving notification from the original manufacturer that microbial detection was found in the factory during environmental monitoring review. After confirming that the batch of drugs met specifications and there were no related adverse event reports, a precautionary recall was initiated considering drug quality and medication safety.

Liu Chia-ping said that the manufacturer has been requested to complete the recall of one batch, totaling 70 bottles already sold, by April 24th, and to submit an investigation report and preventive and corrective measures. If the pharmaceutical company fails to carry out the recall operation as required, it will be fined NT$200,000 to NT$5,000,000 in accordance with Article 91 of the Pharmaceutical Affairs Act.

In addition, Liu Chia-ping stated that according to the company, there are other unaffected batches of drugs, and the inventory is sufficient. Subsequent imports will continue, so there is no concern about drug shortages.

The drug's indication is for the treatment of respiratory distress syndrome (RDS) in premature infants. The FDA reminds that those with concerns about medication should promptly return to their doctor for discussion and prescription of other appropriate drugs. (Editor: Wu Su-jou) 1150409