Drug Safety Alerts

Orphenadrine Citrate ER Tablets Consumer-Level Recall

3/23/2022

On March 23, 2022, the U.S. Food and Drug Administration (FDA) published a notice of a consumer-level recall of multiple lots of Orphenadrine Citrate ER tablets manufactured by Sandoz, Inc. The presence of a nitrosamine (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

A complete list of the affected products can be found here.

Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits. According to Sandoz, 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.

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.

Patients who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription. Consumers should contact their physician if they have experienced any problems that may be related to taking or using this drug product.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Orphenadrine Citrate ER tablets to contact their prescriber.

For more information, please call Sandoz at 1-800-525-8747, Monday – Friday from 8:30 AM to 5:00 PM (EST). You can also email them at qa.drugsafety@sandoz.com. You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.