New Jersey-based drug manufacturer, Sandoz, has recalled 13 lots of its muscle pain and spasm drug, Orphenadrine Citrate 100 mg Extended Release (ER) Tablets, due to higher than acceptable levels of nitrosamine, a compound that has been associated with cancer.
According to a recall notice by the U.S. Food & Drug Administration (FDA), “nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits.”
The recall notice added, “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 recall affects U.S. customers nationwide who received shipments of the drug from August 2019 to April 2021. According to the FDA, 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.
Orphenadrine is the second drug that was recalled on March 21 because of higher-than-acceptable levels of nitrosamine. On March 21, the FDA issued a recall of six lots of Pfizer’s Accuretic, a blood-pressure-lowering medication. The FDA also recalled five lots of generic versions of Accuretic: quinapril and hydrochlorothiazide.
Consumers who are in possession of recalled Orphenadrine Citrate ER Tablets should stop taking the product and immediately consult with their physician to obtain another prescription, the FDA recall notice stated.
The alarm over nitrosamine exposure has been a priority for the FDA since 2018, when high levels of the compound were found in the active ingredient, valsartan, also used for high blood pressure. Drugs with the active ingredients losartan, irbesartan and ranitidine have also been recalled by the FDA.
Ranitidine is the active ingredient in Zantac, a heartburn drug manufactured by GlaxoSmithKline (GSK). An independent laboratory identified ranitidine’s breakdown into nitrosamines, which led to Zantac’s removal from U.S. marketplaces on April 1, 2020 after many consumers filed lawsuits. Thousands of Zantac lawsuits remain pending against GSK.