Sandoz Inc., a generic and biosimilar medicines unit of French drug major Novartis, is recalling 13 lots of oral pain management drug Orphenadrine Citrate 100 mg Extended Release or ER tablets due to the presence of a probable human carcinogen, the U.S. Food and Drug Administration said.
Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and 1000-count bottles and was distributed across the United States to wholesalers and distributors.
The affected 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021.
The Princeton, New Jersey- based company initiated the recall after detecting the presence of a nitrosamine (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, a probable human carcinogen, in the lots during recent testing.
The nitrosamine impurity has the potential to be above the FDA’s Acceptable Daily Intake or ADI limit of 26.5 ng/day.
Nitrosamines are generally found in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines, but exposure to the impurities in higher levels over long periods of time may increase the risk of cancer.
However, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot to date.
Wholesalers and distributors are urged to quarantine and return all recalled product in their inventory. Consumers are asked to stop taking the recalled product and immediately consult with their physician to obtain another prescription.
Earlier this week, drug major Pfizer Inc. recalled certain lots of blood pressure drug Accuretic tablets as well as two authorized generics due to the elevated levels of nitrosamine, N-nitroso-quinapril content, a probable human carcinogen.
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