Mylan ($MYL) has gotten caught up in manufacturing problems at the generics operation of Endo Health Solutions ($ENDP), forcing it to recall three lots of generic Vicodin.
The company announced today that it was recalling the lots of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg made by Endo's Qualitest Pharmaceuticals and repackaged by Mylan. The pills are considered "super potent" because they potentially exceed their prescribed weights.
Endo's issues first surfaced in September, when it recalled one lot of drugs for falling outside weight parameters. Earlier this month it added 100 more lots to the recall. Mylan's recall includes only pills labeled as having 10 milligrams of hydrocodone bitartrate and 500 milligrams of acetaminophen, the active ingredient in Tylenol.
The FDA posted Endo's updated recall to its website warning that liver damage resulting from too much acetaminophen can be lethal. No deaths or problems have surfaced, but the agency pointed out that the danger is particularly acute for anyone "who consumes more than 3 alcoholic beverages a day."
Endo last week downgraded its earnings prospects for this year and next at the same time that it announced that its CEO will retire by May. The company said David P. Holveck, 67, president and CEO, will leave when a successor is named or at the company's annual meeting in May, whichever is earlier. He also will leave the board. Endo said it will look at candidates inside and outside the company.
- here's the release
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