Teva ($TEVA) is expecting to close on its buyout of Allergan’s generic drug business, but for now Actavis is still Allergan’s, for better or worse. That means that Allergan ($AGN) is responsible for the recall of more than 50 lots, consisting of nearly 600,000 bottles, of its copy of the ADHD drug Adderall.
According to the most recent FDA Enforcement Report, Actavis is voluntarily recalling 54 lots involving four different dose forms of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets after they failed tests for impurity levels. The recall was initiated in February but was just classified by the FDA last week as a Class II recall. The nationwide includes 38,507 bottles of 5 mg tablets, 114,388 bottles of 10 mg tablets, 257,746 bottles 20 mg tablets and 182,378 bottles of 30 mg tablets.
The manufacturing mess-up comes as Allergan and Teva are awaiting regulatory approval of their $40.5 billion deal. The two had hoped to close the deal at the end of March, but a couple of weeks ago, Teva said the U.S. Federal Trade Commission said it needed more time to evaluate the massive deal. Now the Israeli drugmaker said the closing might be put off until June.
The European Union signed off on the transaction last month, but with caveats. Teva has to sell off some business to even out the playing field, regulators said. The company agreed to sell "a majority" of Allergan's current generics business in the U.K. and Ireland and agreed to jettison molecules in 24 other countries in Europe. In Iceland, where Actavis originated, Teva will discard its own business while hanging onto the Dublin drugmaker's.
- access the recall notices here