Endo Pharmaceuticals issued a statement warning of possible shortages in the supply of Opana and other painkillers because of the temporary shutdown at a Novartis Consumer Health Inc. drug manufacturing facility in Lincoln, Neb.
In a press release, Endo said some of its other analgesic products could also experience short-term supply disruptions as well because of the shutdown, which took effect following a recent production mix-up at the Lincoln plant.
Endo stressed that it was working with the Food and Drug Administration and Novartis to straighten out the problems and to ensure that new manufacturing process improvements would be made as soon as possible. The company did not say when the Lincoln plant would reopen, but indicated that production of some other effected drugs, such as Percocet and Endocet, would be shifted immediately to a plant in Huntsville, Ala.
In the meantime, Endo officials said they planned to notify doctors “to refrain from starting new patients on Opana in order to minimize disruption for patients currently on the product.”
“We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our products to current patients,” said Endo Chief Operating Officer Julie McHugh.
The company was careful to note that the shutdown, which it said was done to address “rare instances of errors in the packaging” of pills, was not related “to the efficacy or safety of Endo’s products.”
The FDA, meanwhile, indicated that it has no plans to issue a recall of any Endo products based on the shutdown.