In September, the generics subsidiary of Endo Health Solutions ($ENDP) voluntarily recalled one lot of two pain drugs that it called "super potent" because both exceeded their prescribed weights. Now Endo has added 100 more lots to that removal.
The FDA on Thursday posted to its website the updated recall for hydrocodone bitartrate (generic Vicodin) and acetaminophen tablets, which points out that liver damage resulting from too much acetaminophen can be lethal. No deaths or problems have surfaced. The danger is particularly acute for anyone "who consumes more than 3 alcoholic beverages a day."
The drugs are made by Endo's generic unit Qualitest. The suspect lots were distributed to wholesalers and retailers between beginning Feb. 20 and as recently as Nov. 19, the company says. Endo recalled two lots of drugs for a similar problem last year.
Other manufacturers have had to recall products because they fall outside of size specifications. Hospira ($HSP) this year recalled Carpuject cartridges that contained too much hydromorphone, a generic version of Palladone and Dilaudid. And in 2009, federal marshals seized about $20 million worth of products from Caraco after the company had to recall metformin pills for diabetes that fell on both sides of the size specification and were contaminated with metal scrapings.
This situation, however, is particularly dangerous because people taking the pain drug sometimes are also taking other products that contain acetaminophen, like Tylenol, and so are getting higher than recommended doses without being aware. Too much of the active ingredient and patients can be facing enough liver damage to need a transplant.
- here's the notice