Even as generic drugmaker Mylan is dealing with a host of other issues, it is recalling more than 100,000 packages of clonazepam, its generic of Klonopin, a drug that is used to treat seizures and panic disorder.
According to the most recent FDA Enforcement reports, Mylan actually began the voluntary U.S. recall of clonazepam in September after discovering the product was out of spec for a known impurity at the 15 and 16 month testing periods. The report indicated they were manufactured at Mylan’s Morgantown, West Virginia, plant. The FDA only posted the recalls for two different strengths in the last week.
The company is recalling 1,182 unit dose cards of 300 tablets and 52,618 unit dose blister cards of the 0.5 mg tablets, along with another 46,472 unit dose blister cards of the 1.0 mg tablets.
It turns out that at about the same time that Mylan began its recall, Health Canada issued a recall of 1 mg clonazepam tablets manufactured by Canadian company Pharmascience because the lot might also contain tablets of hypertension drug Terazosin-HCl.
The recall is the least of Mylan’s worries these days. The company’s price hikes on the EpiPen have led to a firestorm of controversy. It is currently trying to finalize a $465 million settlement with the Justice Department for Medicaid overcharges for the ephedrine injector.
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The company is also part of a different DOJ investigation, along with lots of other generic drug producers, into potential collusion on prices.