Fresenius said it is working with external experts on an independent investigation of alleged breaches of US Food and Drug Administration data-integrity requirements on product development at Akorn.
“The Management and Supervisory Boards of Fresenius will assess the findings of that investigation,” the company said in a statement late on Monday.
“The consummation of the transaction may be affected if the closing conditions under the merger agreement are not met.”
Akorn said it was looking into the matter and that “to date, the company’s investigation has not found any facts that would result in a material impact on Akorn’s operations and the company does not believe this investigation should affect the closing of the transaction with Fresenius”.
It added that it would continue to work towards obtaining regulatory clearance for a takeover by Fresenius.
Shares in Akorn plunged 30% to US$21 each in US early deals.