Forest Laboratories, now a unit of Actavis ($ACT), has expanded on a recall of one of its key drugs, adding another lot of more than 94,000 cartons of the blood pressure meds to the nationwide retrieval. It is the second recall in three months.
According to an FDA Enforcement Report, Actavis is voluntarily recalling one lot of Bystolic, made up of 94,854 cartons of the blood pressure med because it failed dissolution testing at the 6-month time point. The recall in the U.S. and Puerto Rico is for 20-mg tablets in 7-tablet professional sample bottles.
The drugmaker had already initiated a recall of another lot in June for missing dissolution specs. That lot included 92,544 bottles of the drug.
Bystolic is one of the key drugs that Actavis got in its $25 billion buyout of Forest earlier this year. The blood pressure med sold $455.1 million last year. That was up $107.3 million, nearly 24%, as the drugmaker increased volumes, and pushed up its price ahead of its 2015 patent loss. The drugmaker in February also filed an application of a combo of Bystolic and another blood pressure med, valsartan.