If You Use This Common Medication, Call Your Doctor Now, FDA Warns
This prescription medicine has been recalled, so you'll need to consult a physician.
Those of us who suffer from back pain and muscle aches have tried a variety of medications, both prescription and over-the-counter, to alleviate the discomfort. But if you're using any meds that your doctor prescribed, you'll want to find out about the latest recall, which involves a medication that may be contaminated with a known carcinogen. Read on to find out which pills are being pulled, and what you should do if you have these meds at home.
Sandoz Inc. is recalling 13 lots of Orphenadrine Citrate 100 mg Extended Release (ER) Tablets.
On March 21, pharmaceutical company Sandoz Inc. announced that it was issuing a nationwide recall of 13 lots of Orphenadrine Citrate 100 mg Extended Release (ER) Tablets, according to a release posted on the U.S. Food & Drug Administration (FDA) site on March 22. The presence of a "nitrosamine impurity" was found during recent testing. Nitrosamines have the potential to cause cancer, which is why the FDA puts an Acceptable Daily Intake (ADI) limit on nitrosamine of 26.5 ng/day. The tested Orphenadrine Citrate exceeded that amount.
However, Sandoz has not received any reports of ill effects from customers taking this medication.
Orphenadrine citrate is used to treat muscle spasms and pain.
Orphenadrine citrate is a generic medication that's prescribed to people suffering from muscle spasms or pain, according to WebMD. The site notes that it is used in patients alongside rest and physical therapy. You may have been prescribed this medication under the brand name Norflex. However, this recall applies specifically to pills manufactured by Sandoz Inc.—and only to the Orphenadrine Citrate 100 mg ER Tablets in particular.
The 13 lots recalled by Sandoz were shipped to customers between Aug. 2019 and April 2021. You can find a full list of the lots on the release posted to the FDA site, including the manufacture and expiration dates of each affected product.
The FDA has warned patients about nitrosamine impurities in medication before.
The FDA began setting industry-wide acceptable limits for nitrosamine impurities in medication in 2020, according to the section of the agency's site devoted to this ongoing problem. "Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer," the FDA explains.
Medications that have been pulled from the market for nitrosamine impurities in the past include heartburn medication ranitidine (popularly sold over-the-counter as Zantac) and the diabetes medication metformin.
Here's what to do if you have this recalled medication at home.
Per the FDA release, if you have been taking the recalled Orphenadrine Citrate 100 mg ER Tablets, you should discontinue use right away. But you should also "immediately consult with their physician to obtain another prescription." The release encourages patients who believe they have experienced any negative health effects to talk to their doctor as well. And the FDA also allows you to report any issue with a medication through its MedWatch Adverse Event Reporting.
To return the Sandoz Orphenadrine Citrate 100 mg ER Tablets, you can call or email claims management service Sedgwick, with contact information provided in the FDA release.