EpiPen batch recalled in Singapore after concerns over defects

EpiPen batch recalled in Singapore after concerns over defects

FILE PHOTO: EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo

SINGAPORE: A batch of the EpiPen device, which is used to treat severe allergic reactions in an emergency, has been recalled in Singapore, said the Health Sciences Authority (HSA) on Wednesday (Sep 13).

This follows reports in the United States that the manufacturer, Meridian Medical Technologies, failed to properly investigate problems at its facility in Missouri, leading to defective EpiPens. 

According to a warning letter earlier this month from the US Food and Drug Administration, there were more than 100 complaints that the device malfunctioned during life-threatening emergencies, including situations in which patients died. 

The company, a subsidiary of pharmaceutical giant Pfizer, had in March recalled tens of thousands of EpiPens worldwide, after two reports that the allergy shot failed to work. 

Among the batches of EpiPen 0.3mg/dose and EpiPen Jr 0.15mg/dose recalled, one batch was distributed in Singapore, said a spokesperson from HSA.

The spokesperson added that the affected batch (6GM088) has been recalled by the local distributor in early April, and there have been no reports of EpiPen failures in Singapore. 

"The manufacturer has taken measures to correct the root cause, including improving the design of the EpiPen Auto-injector device, to prevent future occurrences," said the spokesperson. "HSA will continue to monitor the situation and the effectiveness of the actions taken."

Source: CNA/gs