Generic drugmaker Mylan NV has recalled about 81,000 EpiPen devices in countries outside the United States, following two reports of the life-saving allergy shot failing to work in emergencies.
In both situations, patients were able to obtain treatment through the use of an alternate EpiPen, Mylan said on Wednesday.
The recall affects devices distributed in Australia, New Zealand, Europe and Japan only, according to the company.
Mylan said it is working with the regulatory authorities, where appropriate, to inform them about the recall.
The U.S. drugmaker, which is the focus of multiple federal investigations, has come under fire for staggering price increases on the emergency shot in the United States.
Mylan has also been heavily criticized for classifying EpiPen as a generic rather than a branded product, which led to much smaller rebates from the company to state Medicaid programs.
The story was refiled change the headline to say 81,000 EpiPens were recalled.
Reporting by Natalie Grover in Bengaluru; Editing by Sai Sachin Ravikumar and Shounak Dasgupta.