Right on the heels of Pfizer’s Accuretic recall, nitrosamine impurities have forced another major drugmaker to pull certain meds from U.S. shelves.
Novartis’ Sandoz is recalling 13 lots of oral orphenadrine citrate 100-mg extended-release tablets after testing flagged unacceptable levels of a potential carcinogen dubbed NMOA, or Nitroso-Orphenadrine.
Nitrosamines, which are also found in the air, drinking water, dairy products, vegetables and cured and grilled meats, can cause cancer after long-term, high-level exposure.
“While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot,” the company said in a notice published by the U.S. FDA.
Sandoz’s orphenadrine tablets are used alongside rest, physical therapy and other measures for discomfort relief linked with acute painful musculoskeletal conditions, the company said. The product comes in 100-count and 1,000-count bottles that were shipped out across the U.S.
Sandoz produced the lots in question between May 24, 2019, and Nov. 18, 2020, according to the FDA’s recall notice. They were set to expire as early as May of this year and as late as November 2023.
The Novartis unit pointed out that the recall is specific to the 13 named lots “and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER tablets nor to other lot numbers of the product.”
Patients who have orphenadrine tablets from the suspect lots should stop using the drug and “immediately” reach out to their doctor for an alternative, Sandoz said.
Sandoz’s drug is just the latest casualty in a nitrosamine impurity parade that’s been rolling on for years now. Earlier this week, Pfizer issued a voluntary recall of its blood pressure drug Accuretic, plus a pair of hypertension therapies distributed by Greenstone, also on nitrosamine concerns.
Pfizer's U.S. product pull followed twin Canadian recalls earlier this month, which covered Accuretic plus another blood pressure medicine, Inderal.
Last June, meanwhile, Pfizer halted global distribution of smoking cessation med Chantix on similar impurity woes.
Over the past several years, many drugmakers have had to yank valsartan blood pressure meds and metformin diabetes drugs over excess levels of another type of nitrosamine dubbed N-Nitrosodimethylamine.