The FDA has cited two of Endo's ($ENDP) units in its latest enforcement report, calling for separate recalls of two drugs.
The agency issued a Class II recall of 12.5-mg tablets of hydrochlorothiazide capsules that are used to treat high blood pressure that were produced by Vintage Pharmaceuticals (a subsidiary of Endo), which is doing business as Qualitest Pharmaceuticals. The recall was issued due to the presence of particulate matter.
Separate Class III recalls were issued for both 12.5-mg and 25-mg prescription-only tablets of meclizine hydrochloride, which is typically used to prevent and treat nausea, vomiting and dizziness caused by motion sickness or inner ear problems. The drug was manufactured by Par Pharmaceuticals, which was acquired by Endo earlier this year.
|Endo CEO Rajiv De Silva|
The cause for the Class III recall, the least serious of the agency's recalls, was due to failed impurities/degradation specifications.
Endo snapped up generics maker Par for $8 billion earlier this year as part of an effort to grow Endo's injectables portfolio. The Dublin-based Endo was looking to generate double-digit revenue growth with the acquisition and help ramp up its Qualitest generics business that CEO Rajiv De Silva described at the time of the purchase as an "extremely attractive and effective growth driver."
- check out the FDA enforcement report