Drug recall notice for orphenadrine citrate tablets

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the recall of 13 lots of oral orphenadrine citrate 100 mg extended-release tablets to the consumer level on March 22, 2022.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall.

The drug manufacturer, Sandoz Inc., is voluntarily recalling these products due to the presence of a nitrosamine (N-methyl-N-nitroso-2-[(2-methylphenyl) phenylmethoxy] ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to exceed the U.S. Food and Drug Administration (FDA) Acceptable Daily Intake limit of 26.5 ng/day. The impurity was detected in the lots during recent testing.

Other lot numbers of orphenadrine citrate are unaffected and readily available.

Medications included in this recall

Visit the FDA website for specific details about the recalled medication.

Information for providers:1

  • We have sent a letter to your Humana-covered patients who have had a claim for orphenadrine citrate and asked them to contact their physicians or healthcare providers if their medication is included in the recall and if they have experienced problems that may be related to using these drug products.
  • To return the recalled product, healthcare providers can contact Sedgwick directly by phone at 844-491-7869, Monday – Friday, 8 a.m. – 5 p.m., Eastern time. Providers can also email sandoz4887@sedgwick.com.
  • To report an adverse reaction, please contact Sandoz by phone at 800-525-8747 or by email at qa.drugsafety@sandoz.com. Customer service agents are available Monday – Friday, 8:30 a.m. – 5 p.m., Eastern time.
  • Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
    • Online: Complete and submit the report.
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form.
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

Reference:

  1. “Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity,” U.S. Food and Drug Administration, last accessed March 29, 2022, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due.