The generics subsidiary of Endo Health Solutions is voluntarily recalling one lot of both hydrocodone bitartrate (generic Vicodin), and acetaminophen.
The FDA notice says there have been no injuries reported but the tablets, made by Qualitest, may exceed their weights and so be "super potent." Taking too much acetaminophen creates a risk for liver damage, particularly for those who have liver disease or who consume more than three alcoholic drinks a day, the FDA says.
Endo ($ENDP) recalled two lots of drugs for a similar problem last year. It also earlier this year had to recall some of its high-powered, prescription-only opioid drugs made at a plant in Nebraska that Novartis ($NVS) had to close because of extensive problems. In that case, some Novartis products might have made their way into packages of Endo's painkillers.
The FDA is asking retailers to check their supplies, segregate any that are from the recalled lots and notify Qualitest.
- here's the FDA notice
Packaging problems prompt Endo painkiller recall
FDA: Endo opioids may be mixed in Novartis OTC packages