13 Lots of Muscle Pain Pills Recalled by Sandoz for Containing Ingredient at Carcinogenic Levels

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Orphenadrine Citrate 100 mg Extended Release (ER) Tablets Recall Overview:

• Who: New Jersey-based drug manufacturer Sandoz is recalling 13 lots of its oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets.
• Why: The pills may contain nitrosamine above the Food and Drug Administration’s Acceptable Daily Intake limit. Nitrosamines are substances with carcinogenic potency.
• Where: The recall is effective nationwide in the United States.

New Jersey-based drug manufacturer Sandoz is recalling 13 lots of its oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets due to the pills containing an ingredient at possibly carcinogenic levels.

In a recall notice posted by the U.S. Food and Drug Administration (FDA), the company says the pills, used to treat muscle pains and spasms as an adjunct to rest, physical therapy and other measures, contain nitrosamine above the FDA’s Acceptable Daily Intake limit.

High Nitrosamine Exposure Can Lead to Cancer

“Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits,” the recall notice says. “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 13 lots of Orphenadrine Citrate ER Tablets were packaged in 100-count and 1,000-count bottles and distributed nationwide to customers from August 2019 to April 2021. For a full list of recalled products, click here.

Consumers who have the recalled Orphenadrine Citrate ER Tablets should stop taking them and immediately consult with their physician to obtain another prescription, Sandoz says.

“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” according to the company. 

The recall comes a day after Pfizer recalled 11 lots of hypertension medications due to containing high levels of the same carcinogenic chemical compound. Pfizer said it was voluntarily recalling six lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets, as well as one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets distribute by Greenstone due to the presence of a nitrosamine, N-nitroso-quinapril, above the acceptable daily intake level. 

Let us know in the comments section if you are affected by this recall!

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