Endo reports oversized problem with oversized pain meds
What started out three months ago as a single-lot recall of pain meds that Endo Health Solutions ($ENDP) said might exceed their size limits has turned into a recall of 101 lots, some of them shipped two months after the initial yellow flag was waved.
In September, Endo's generics unit Qualitest voluntarily recalled one lot of both hydrocodone bitartrate (generic Vicodin) and acetaminophen because tablets may have exceeded their prescribed weights, making them "superpotent." Now it is adding 100 more lots to the recall.
Besides the possibility of oversedation, with acetaminophen there is always a risk of liver damage, even to the point of requiring a transplant. The risk is increased for anyone who consumes more than "3 alcoholic beverages a day," the recall notice says.
Endo had to recall some pain meds last year when some bottles were mislabeled and some larger pills were found in bottles not labeled to contain them. And earlier this year, some of its products got mixed up with the huge problems the Novartis OTC plant in Lincoln, NE, was found to have. The FDA warned that it was possible that some of Endo's painkillers made at the plant could have gotten mixed in with Novartis ($NVS) Gas-X tablets.
- here's the notice
Endo revises pain drug recall from 1 to 101 lots
Endo recalls potentially 'super potent' painkillers
Endo illustrates two types of labeling recalls
FDA: Endo opioids may be mixed in Novartis OTC packages