Sandoz on March 22 issued a voluntary recall of 13 lots of oral orphenadrine citrate 100 mg extended release tablets because of possible elevated levels of a nitrosamine.
The drug is used to treat muscle spasms and pain alongside physical therapy and rest. The recalled lots of orphenadrine citrate ER tablets were shipped to customers from August 2019 to April 2021.
"Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits," the company said. "While the use of product belonging to the recalled lots may present 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."
Sandoz, Novartis' generic drug unit, said it has started contacting wholesalers and distributors and is arranging for the return of recalled products.
To view details of the recalled lots, click here.