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Briefs

October 12, 2018

UK Extends Expiration Dates for EpiPens to Cope With Shortages

The UK’s Medicines and Healthcare products Regulatory Agency extended the expiration dates on Mylan’s EpiPen to deal with looming shortages due to ongoing supply issues with Mylan’s contract manufacturer, Meridian Medical Technologies.

The EpiPen and EpiPen Junior adrenaline auto-injector pens are expected to be in limited supply for the remainder of 2018. To deal with the shortage, MHRA has allowed the company to extend the expiration dates by four months.

Mylan is out of stock of the EpiPen Junior 150 mcg, and a limited supply is expected in October, with additional deliveries in November. The UK notes that children over 30 kg should use the EpiPen Junior 300 mcg pen.

There are two alternative adrenaline auto-injector devices available: Bausch & Lomb’s Emerade and ALK’s Jext. Both companies are aware of the supply disruptions and are working with their supply chains to increase supply to the UK for the remainder of the year, the MHRA said.

MHRA Recalls Digital Pregnancy Tests

The UK’s Medicines and Healthcare products Regulatory Agency Issued a recall for Wondfo Clear & Simple digital pregnancy tests due to a number of false positive results from the tests manufactured by the Guangzhou, China-based company.

Wondfo reported that some of the test kits could deliver false readings, attributing the problem to a large gap between the test strip bracket and the plastic enclosure of the test kit that allowed a change in light to affect the tests.

The recall affected one lot involving 58,000 tests distributed in the UK, according to the MHRA.