A couple of years ago, Endo ($ENDP) decided to put a bunch of money into its Alabama plant where its Qualitest unit makes generics. But that facility has recently been tripped up by some manufacturing issues and is now recalling a couple of drugs, some for being outsized and off color.
According to the FDA's most recent Enforcement Report, Qualitest is recalling 21,552 units of allopurinol tablets used to treat gout and kidney stones. The voluntary recall was initiated after getting reports of "oversized and discolored tablets," the report says. It is also recalling 8,705 bottles of blood pressure med lisinopril tablets for being out of spec. Both were manufactured at its Qualitest plant in Huntsville, AL, where in 2013, it started work on about $100 million in upgrades.
Endo is one of the largest producers of controlled substances in the U.S., and the Qualitest product mix is about 45% controlled substances plus other liquid products and a variety of solid-dose generic meds.
But now the Dublin, Ireland-based company is is beefing up its generics business and putting itself squarely in the sterile injectables space with an $8 billion bid for Par Pharmaceutical. When it announced the deal in May, it said the purchase would ramp up its Qualitest generics business by adding 100 products from Par--including its generic injectables--that together accounted for $1.3 billion in 2014 sales. Par had expanded its sterile injectables business the year before with a $490 million deal for JHP.
- read the recall notices here and here