The manufacturing problems at the Novartis plant east of Lincoln apparently extend beyond its own brand.
The Food and Drug Administration on Monday warned that several high-powered painkillers Novartis makes in Lincoln for Endo Pharmaceuticals could be contaminated with other drugs.
The FDA said an inspection of the Lincoln plant found a packaging problem that could allow a pill, tablet or caplet to get mixed in with a different prescription, although the agency said the possibility of that happening is unlikely.
"The likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low, and patients should not be unduly alarmed," FDA's Dr. Edward Cox told The Associated Press. Cox went on to say that FDA inspectors currently are inspecting the plant and uncovered a manufacturing problem that could allow pills to become stuck in the machinery and carry over to the packaging of other products. FDA officials said the investigation is ongoing and would not comment on potential penalties against Endo or Novartis.
The drugs made for Endo by Novartis in Lincoln are: Percocet, Percodan, Opana, Opana ER, Endocet, Endodan, Oxymorphone, Zydone and generic morphine.
The FDA did not recall the drugs but said anyone with a prescription for one of them should check to make sure all of the pills in the bottle are the same color and shape. Anyone who finds discrepancies should contact his or her pharmacist, the FDA said.
Endo Pharmaceuticals, in a news release, also warned of shortages of some of the painkillers because of the shutdown of the Lincoln Novartis plant.
The company closed down the plant Dec. 19, saying it needed to do maintenance and upgrade standards.
Although Novartis has said the shutdown is voluntary, an FDA inspection last summer uncovered numerous instances of packaging mixups, and a lack of quality-control that included the failure to investigate some complaints.
On Sunday, Novartis announced a recall of Excedrin, No-Doz, Bufferin and Gas-X products because they may contain broken or stray tablets from other products.
Julie Masow, a Novartis spokeswoman, said the company has had no reports of any Endo products being mixed in with Novartis products or vice versa. She also said there have been no reports of adverse reactions to any of the recalled products.
Masow said Novartis manufactures some Endo products in Lincoln, but she would not elaborate. Novartis has for years described its Lincoln plant's business as over-the-counter drug manufacturing.
Julie McHugh, chief operating officer of Endo Pharmaceuticals, said in a news release that the Lincoln Novartis plant is the sole manufacturer of the current formulation of Opana ER (extended release).
McHugh said Endo was recommending doctors not start any new patients on Opana ER to help manage the potential shortage.
The company also said there could be shortages of some of the other drugs manufactured in Lincoln by Novartis and that it is working with Novartis and the FDA to get production restarted in Lincoln.
Novartis has given no indication as to when it might restart production at the Lincoln plant. The company also said it will take a $120 million charge against its fourth-quarter earnings for the shutdown and recall.
The company so far has not laid off any permanent employees in Lincoln. Masow said there are 620 permanent employees and about 200 temporary employees working at the plant.